Medical Device Reporting: Electronic Submission Requirements, 42203-42217 [E9-19683]
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Federal Register / Vol. 74, No. 161 / Friday, August 21, 2009 / Proposed Rules
(iii) Patient gender; and
(iv) Patient weight.
(2) Adverse experience.
(i) Outcome attributed to adverse
experience;
(ii) Date of adverse experience;
(iii) Date of report;
(iv) Description of adverse experience;
(v) Description of relevant tests,
including dates and laboratory data; and
(vi) Other relevant patient history,
including preexisting medical
conditions.
(3) Suspect medical product(s).
(i) Name;
(ii) Dose, frequency, and route used;
(iii) Therapy dates;
(iv) Diagnosis for use (indication);
(v) State whether adverse experience
abated after product use stopped or dose
reduced;
(vi) Lot number;
(vii) Expiration date;
(viii) State whether adverse
experience reappeared after
reintroduction of the product;
(ix) NDC number, or other unique
identifier; and
(x) Concomitant medical products and
therapy dates.
(4) Initial reporter information.
(i) Name, address, and phone number;
(ii) Whether the initial reporter is a
health professional;
(iii) Occupation; and
(iv) Whether the initial reporter also
sent a copy of the report to FDA.
(5) Applicant information.
(i) Applicant name and contact office
address;
(ii) Telephone number;
(iii) Report source(s) (e.g., literature,
study);
(iv) Date received by applicant;
(v) Application number and type;
(vi) Type of report being submitted
(e.g., 15-day, periodic, followup);
(vii) Adverse experience term(s); and
(viii) Manufacturer report number.
(g) Electronic format for submissions.
(1) Safety report submissions, including
ICSRs and any attached documentation
and the descriptive information in
periodic reports, must be in an
electronic format that FDA can process,
review, and archive. FDA will
periodically issue guidance on how to
provide the electronic submission (e.g.,
method of transmission, media, file
formats, preparation and organization of
files).
(2) Waivers. Persons subject to the
requirements of paragraph (c) of this
section may request, in writing, a
temporary waiver of the requirements in
paragraph (g)(1) of this section. These
waivers will be granted on a limited
basis for good cause shown. If the
agency grants the waiver, the person
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must submit reports required under this
section on paper within the required
time periods in a form that FDA can
process, review, and archive. FDA will
issue guidance on how to provide the
paper submission. Requests for waivers
must be submitted in accordance with
§ 600.90.
*
*
*
*
*
(i) Patient privacy. For nonvaccine
biological products, an applicant should
not include in reports under this section
the names and addresses of individual
patients; instead, the applicant should
assign a unique code to each report. The
preferred methodology for determining
the identification code will be set forth
in guidance. The applicant should
include the name of the reporter from
whom the information was received,
unless the reporter is the patient. The
names of patients, health care
professionals, hospitals, and
geographical identifiers in adverse
experience reports are not releasable to
the public under FDA’s public
information regulations in part 20 of
this chapter. For vaccine adverse
experience reports, these data will
become part of the CDC Privacy Act
System 09–20–0136, ‘‘Epidemiologic
Studies and Surveillance of Disease
Problems.’’ Information identifying the
person who received the vaccine or that
person’s legal representative will not be
made available to the public, but may be
available to the vaccinee or legal
representative.
*
*
*
*
*
8. Section § 600.81 is amended:
a. By removing the phrase ‘‘licensed
manufacturer’’ each time it appears and
by adding in its place the word
‘‘applicant’’;
b. By designating the existing text as
paragraph (a) and by adding a new
heading for paragraph (a); and
c. By adding new paragraph (b) to
read as follows:
§ 600.81
Distribution reports.
(a) Reporting requirements. * * *
(b)(1) Electronic format. Except as
provided for in paragraph (b)(2) of this
section, the distribution reports required
under paragraph (a) of this section must
be submitted to the agency in electronic
format in a form that FDA can process,
review, and archive. FDA will
periodically issue guidance on how to
provide the electronic submission (e.g.,
method of transmission, media, file
formats, preparation and organization of
files).
(2) Waivers. An applicant may
request, in writing, a temporary waiver
of the requirements in paragraph (b)(1)
of this section. These waivers will be
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granted on a limited basis for good
cause shown. If the agency grants the
waiver, the applicant must submit
reports required under this section on
paper within the required time period in
a form that FDA can process, review,
and archive. FDA will issue guidance on
how to provide the paper submission.
Requests for waivers must be submitted
in accordance with § 600.90.
§ 600.90
[Amended]
9. Section 600.90 is amended by
removing the phrase ‘‘licensed
manufacturer’’ each time it appears and
by adding in its place the word
‘‘applicant’’.
Dated: August 5, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–19682 Filed 8–20–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 803
[Docket No. FDA–2008–N–0393]
RIN 0910–AF86
Medical Device Reporting: Electronic
Submission Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
SUMMARY: The Food and Drug
Administration (FDA) is proposing to
amend its postmarket medical device
reporting regulation to require that
manufacturers, importers, and user
facilities submit mandatory reports of
individual medical device adverse
events, also known as medical device
reports (MDRs) to the agency in an
electronic format that FDA can process,
review, and archive. Mandatory
electronic reporting would improve the
agency’s process for collecting and
analyzing postmarket medical device
adverse event information. The
proposed regulatory changes would
provide the agency with a more efficient
data entry process that would allow for
timely access to medical device adverse
event information and identification of
emerging public health issues.
Elsewhere in this issue of the Federal
Register, FDA is also announcing a draft
guidance document that provides
recommendations on how to prepare
and submit electronic MDRs to FDA in
a manner that satisfies the requirements
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Federal Register / Vol. 74, No. 161 / Friday, August 21, 2009 / Proposed Rules
of this proposed regulation. The
proposal also includes modifications to
the regulations specifying the content of
required MDRs to better track
information already solicited on the
FDA Form 3500A.
DATES: November 19, 2009. Submit
comments on information collection
issues under the Paperwork Reduction
Act of 1995 (the PRA) by September 21,
2009, (see the ‘‘Paperwork Reduction
Act of 1995’’ section of this document).
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2008–N–
0393 and/or RIN number 0910–AF86, by
any of the following methods, except
that comments on information
collection issues under the Paperwork
Reduction Act of 1995 must be
submitted to the Office of Regulatory
Affairs, Office of Management and
Budget (OMB) (see the ‘‘Paperwork
Reduction Act of 1995’’ section of this
document).
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
To ensure more timely processing of
comments, FDA is no longer accepting
comments submitted to the agency by email. FDA encourages you to continue
to submit electronic comments by using
the Federal eRulemaking Portal, as
described previously, in the ADDRESSES
portion of this document under
Electronic Submissions.
Instructions: All submissions received
must include the agency name and
Docket No(s). and Regulatory
Information Number (RIN) (if a RIN
number has been assigned) for this
rulemaking. All comments received may
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number(s), found in brackets in
the heading of this document, into the
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‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Information Collection Provisions:
The information collection provisions of
this proposed rule have been submitted
to OMB for review. Interested persons
are requested to fax or e-mail comments
regarding the information collection
provisions by September 21, 2009, to
the Office of Information and Regulatory
Affairs, OMB. To ensure that comments
on information collection are received,
OMB recommends that written
comments be faxed to 202–395–7285 or
e-mailed to
OIRA_submission@omb.eop.gov. Please
reference this proposed rule and OMB
Control Number 0910–0437 and mark
your comments to the Attention of the
FDA Desk Officer.
FOR FURTHER INFORMATION CONTACT:
Howard Press, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Building 66, rm. 3320, Silver
Spring, MD 20993–0002, 301–796–6087.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Introduction
A. What Are the Medical Device
Reporting Requirements?
1. What Are the Current Reporting
Requirements for Manufacturers
and What Is Their Status?
2. What Are the Current Reporting
Requirements for Importers?
3. What Are the Current Reporting
Requirements for User Facilities?
B. What Format Is Currently Used for
Submitting Postmarket Medical
Device Reports?
C. Why Is FDA Proposing to Require
Electronic Submissions of MDRs?
1. What Are the Options for Electronic
Reporting?
2. What Is the FDA Electronic
Submission Gateway (ESG)?
3. How Do I Know FDA Received My
Electronic Submission and It Was
Successfully Processed?
II. Description of the Proposed Rule
A. How Would the Rule Address
Submission of Reports in Electronic
Format?
1. How Would the Reporting
Requirements for Manufacturers
Change With Respect to Electronic
Format?
2. How Would the Reporting
Requirements for Importers Change
With Respect to Electronic Format?
3. How Would the Reporting
Requirements for User Facilities
Change With Respect to Electronic
Format, and How Would Annual
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Report Requirements be Affected?
4. How Would the Requirement to
Submit Reports in Electronic
Format Affect Recordkeeping
Requirements?
B. How Would I Submit MDRs in
Electronic Format?
C. How Can a Medical Device
Manufacturer, Importer, or User
Facility Obtain a Variance
Regarding the Requirement to
Submit a Report in Electronic
Format?
D. What Other Changes Are Being
Proposed?
E. When Would the Rule Become
Effective?
III. What Is the Legal Authority for This
Rule
IV. Is There an Environmental Impact?
V. Analysis of Impacts
A. Benefits
B. Costs
1. One-Time Costs
a. Rewriting SOPs and training
personnel
b. Setting up systems for submission
c. Electronic certificates
2. Annual costs
a. Maintaining electronic certificates
b. High-speed Internet access
C. Summary of Benefits and Costs
D. Alternatives Considered
E. Regulatory Flexibility Analysis
VI. Paperwork Reduction Act of 1995
A. Reporting Requirements
B. Recordkeeping Requirements
C. Total Annual Cost Burden
VII. Federalism
VIII. Request for Comments
IX. References
I. Introduction
In this proposal, we provide
background information on the current
status of FDA’s medical device reporting
requirements, explain the revisions we
are proposing here, and describe our
approach to electronic medical device
reporting.
For over 20 years, FDA has received
postmarket MDRs in a paper format.
This proposed rule to require the
electronic submission to FDA of most
MDRs is an important step towards
improving the agency’s systems for
collecting and analyzing postmarket
MDRs. The proposed rule includes
reports of deaths, serious injuries, and
malfunctions that must be reported to
FDA in initial 5-day, 10-day, or 30-day
individual MDRs or in supplemental
reports. We believe this proposed rule
would have the following benefits:
• Reduce industry’s time and costs
associated with transcribing data from
internal data management systems to
paper and mailing the paper reports to
the agency,
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• Eliminate the agency’s transcription
errors, time, and costs associated with
receiving paper reports and transcribing
data to electronic format for review and
analysis,
• Expedite the agency’s access to
safety information in a format that
would support more efficient and
comprehensive data analysis and
reviews, and
• Enhance the agency’s ability to
rapidly communicate information about
suspected problems to the medical
device industry, health care providers,
consumers, and other government
agencies.
In addition, this proposed rule is
consistent with the Government
Paperwork Elimination Act (Public Law
105–277) requirement that Federal
agencies allow individuals or entities to
submit information or transact business
with the agency electronically.
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A. What Are the Medical Device
Reporting Requirements?
The requirements of current medical
device reporting regulations are
summarized in sections I.A.1 to I.A.3 of
this document. In addition, we address
changes to these regulations to be
effected outside of this proposed rule.
Current MDR regulations (part 803 (21
CFR part 803)) require manufacturers
and importers of marketed medical
devices, and user facilities, to submit
postmarket reports of individual
medical device adverse events to FDA
on the FDA Form 3500A.
1. What Are the Current Reporting
Requirements for Manufacturers and
What Is Their Status?
The current MDR regulation requires
that manufacturers of medical devices
submit a postmarket MDR of an
individual adverse event no later than
30 calendar days after becoming aware
of information that a device the
manufacturer markets may have caused
or contributed to a death, serious injury,
or malfunction (§ 803.50). This report
must be submitted on the FDA Form
3500A, (§ 803.20), and contain
information described in § 803.52.
In addition, the regulation requires
manufacturers to provide supplemental
information about such events, on an
FDA Form 3500A, within 30 calendar
days of obtaining information should
such information become available after
the initial MDR was filed with FDA
(§ 803.56). In instances where the
medical device adverse event resulted
in remedial action to prevent an
unreasonable risk of substantial harm to
the public health, or at the discretion of
the agency, the regulation requires the
manufacturer to submit an MDR to the
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agency no later than 5 working days
after becoming aware of the information
(§ 803.53).
Title II, section 227, of the Food and
Drug Administration Amendments Act
of 2007 (FDAAA) (Public Law 110–85),
amended section 519 of the Federal
Food, Drug, and Cosmetic Act (the act)
to require that FDA establish criteria for
manufacturer reports of malfunctions
for most class I and certain class II
devices that include requiring those
reports to be in summary form and
made on a quarterly basis. The types of
events required to be reported are
unchanged. FDA intends to address
changes necessitated by this statutory
change separately from this proposed
rule, and will address requirements for
submission of those new summary
malfunction reports at that time.
However, some individual malfunction
reports will continue to be required
even after the FDAAA-related changes,
and as explained below, the rule
proposed here does address submission
of individual malfunction reports to the
agency.
2. What Are the Current Reporting
Requirements for Importers?
The MDR regulation requires that
importers of medical devices submit a
postmarket MDR to the agency and the
manufacturer no later than 30 calendar
days after becoming aware of
information that reasonably suggests
that one of the importer’s marketed
devices may have caused or contributed
to a death or serious injury (§ 803.40(a)).
Importers must submit reports to the
manufacturer no later than 30 calendar
days after becoming aware of
information that reasonably suggests
that one of the importer’s marketed
devices has malfunctioned and that this
device or a similar device marketed by
the importer would be likely to cause or
contribute to a death or serious injury if
the malfunction were to recur
(§ 803.40(b)). These reports must be
submitted on the FDA Form 3500A (see
§ 803.20) and contain the information
specified in § 803.42.
3. What Are the Current Reporting
Requirements for User Facilities?
The MDR regulation requires that user
facilities submit a postmarket MDR of
death to the agency and an MDR of
death or serious injury to the device
manufacturer within 10 working days of
becoming aware of information that
reasonably suggests that a device has or
may have caused or contributed to the
death or a serious injury of a patient of
the facility. (§ 803.30(a)). The regulation
requires that user facilities submit
postmarket reports of serious injury to
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42205
the agency within 10 working days if
the manufacturer of the device is
unknown or cannot be identified
(§ 803.30(a)(2)). These reports must be
submitted on the FDA Form 3500A (see
§ 803.20(a)), and include the
information described in § 803.32.
In addition, user facilities are required
to submit to the agency an annual
summary of the reports they sent to
manufacturers and the FDA, using FDA
Form 3419 (§ 803.33). The proposal to
require submission of reports to FDA in
an electronic format does not apply to
user facility annual reports made under
§ 803.33, although other changes to
§ 803.33 are proposed as explained in
section I.B of this document.
B. What Format Is Currently Used for
Submitting Postmarket Medical Device
Reports?
Current regulations at § 803.20(a)
require that user facilities, importers,
and manufacturers use the FDA Form
3500A to submit mandatory reports
about FDA-regulated devices. This
requirement took effect July 31, 1996
(see 60 FR 63578, December 11, 1995;
61 FR 16043, April 11, 1996).
Certain blocks of the FDA Form
3500A are required only for user
facilities, while others are required only
for manufacturers (see § 803.20(a)(2)).
Subsequent to its initial adoption,
FDA revised the Form 3500A and its
instructions, adding elements including
the premarket approval application
(PMA) or 510(k) number for the device,
and two questions regarding
reprocessed single-use devices. The
agency was required to revise the form
to include the questions regarding
reprocessed single-use devices under
section 303 of the Medical Device User
Fee and Modernization Act of 2002
(Public Law 107–250). The revised FDA
Form 3500A is approved under the
PRA, under OMB control number 0910–
0291.
FDA Form 3500A has been routinely
completed on paper and transmitted to
FDA by mail, requiring FDA to
manually input information from those
reports into its internal electronic
systems before it can be reviewed and
analyzed. This process is extremely time
consuming, costly, and susceptible to
data entry errors. Because FDA
regulations at § 803.14 provide for the
possibility of voluntary electronic
submission of MDRs, with agency
permission, several regulations in part
803 refer to submission of reports using
the FDA Form 3500A ‘‘or an electronic
equivalent approved under section
803.14.’’ (See, e.g., §§ 803.30, 803.40,
and 803.53.) However, reporters have
not made use of section 803.14 to
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pursue voluntary electronic submission
of MDRs, and FDA’s legacy systems
were not in general designed to accept
submission of MDRs in electronic
format.
C. Why Is FDA Proposing to Require
Electronic Submission of MDRs?
When a medical device has been
cleared for marketing and enters the
market, the product is introduced to a
larger patient population in settings
different from clinical trials. New
information generated during the
postmarketing period offers further
insight into the benefits or risks of the
product, and evaluation of this
information is important for all products
to ensure their safe use. Historically,
FDA has received almost all postmarket
MDRs on paper through the mail. When
data elements are provided to FDA on
only paper, the information must be
entered by hand into an electronic
format for review and analysis. This
process is extremely time consuming,
costly, and susceptible to data entry
errors.
The electronic submission of medical
device reports would lead to more
efficient reviews, enhancing our ability
to rapidly disseminate significant
information to the medical device
industry, health care providers, and
consumers, in support of FDA’s public
health mission.
Electronic submissions would also
improve the speed and efficiency of
both industry and agency operations.
Electronic reporting can benefit industry
by reducing the costs associated with
collating, copying, storing, retrieving,
and mailing paper medical device
reports to the agency on FDA Form
3500A. In addition, the agency benefits
from the elimination of manual data
entry processes and reductions in
physical storage for paper copies of the
FDA Form 3500A. Based on low rates of
participation in prior pilot voluntary
electronic MDR submission programs,
FDA believes that without a regulation
requiring electronic submission of
MDRs a large number of medical device
firms and user facilities would resist
changing their procedures for a long
period of time. This delay would hinder
our achieving the benefits of
standardized formats and quicker access
to MDR data.
1. What Are the Options for Electronic
Reporting?
FDA’s Center for Devices and
Radiological Health (CDRH) has
established its MDR databases currently
to support two options for electronic
submission of MDRs: One designed for
low volume reporting and one designed
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for high volume reporting. Both options
make use of the FDA Electronic
Submission Gateway (FDA ESG), a
secure electronic portal described
further in this document, for
transmission of reports to FDA. In
accordance with 21 CFR 11.2(b), CDRH
is now accepting on a voluntary basis,
in lieu of paper, MDRs prepared and
transmitted in accordance with these
options. More information on electronic
submission of MDRs is available at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
PostmarketRequirements/Reporting
AdverseEvents/ucm127932.htm.
For low-volume medical device
reporting (few or infrequent MDRs), the
current approach developed by the
agency uses the CDRH eSubmitter
(CeSub) software. The CeSub software
allows for the submission of one MDR
at a time. The software provides the
following tools:
• Save address and contact
information,
• Search for a Product Code,
• Search to locate a patient or Device
Problem Code,
• Search to find manufacturer
evaluation codes (method, result, and
conclusion),
• Attach documents when additional
information needs to be provided,
• Produce a ‘‘missing data report’’ to
help ensure that all required
information is supplied before
submission to FDA.
Once the MDR is completed, the file
is ‘‘packaged for submission.’’ The
package generates an electronic version
of the FDA Form 3500A, which can be
submitted to FDA using the FDA ESG.
The final CeSub-generated report can
also be saved or printed, for
recordkeeping or to provide reports to
manufacturers or other entities outside
of FDA. The CeSub software and
instructions for installation are free and
available at: https://www.fda.gov/
ForIndustry/FDAeSubmitter/
ucm107903.htm. We may sometimes
update or change our methodology,
approach or software to improve the
low-volume reporting experience.
Reporters with large volumes of MDRs
may prefer the second option, called the
Health Level 7 Individual Case Safety
Report (HL7 ICSR). The HL7 ICSR was
developed in conjunction with the HL7
standards organization to support the
exchange of electronic data. This option
allows for the extraction directly from
the reporter’s database of information to
populate an MDR, production of the
appropriate data output, and
transmission of the MDRs to the FDA
ESG. The HL7 ICSR supports the batch
submission of more than one individual
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MDR at a time. Reporters developing
applications using the HL7 ICSR
standard may also build functions for
saving or printing those reports.
The draft guidance document
announced elsewhere in this Federal
Register provides information on both
options for electronic submission of
MDRs.
2. What Is the FDA Electronic
Submission Gateway (ESG)?
The FDA ESG is the entry point for all
electronic submissions to the agency.
The FDA ESG is available 24 hours a
day, 7 days a week. Information on the
FDA ESG is available at https://
www.fda.gov/ForIndustry/Electronic
SubmissionsGateway/default.htm. To
use the FDA ESG, reporters need to have
a digital certificate. A digital certificate
is an attachment to an electronic
message that allows the recipient to
authenticate the identity of the sender
via third party verification from an
independent certificate authority.
Digital certificates are used to identify
encryption and decryption codes
between message senders and
recipients. Information on digital
certificates can be found at https://
www.fda.gov/ForIndustry/Electronic
SubmissionsGateway/ucm113223.htm.
3. How Do I Know FDA Received My
Electronic Submission and It Was
Successfully Processed?
FDA’s electronic submission
processing system sends the submitter
three different acknowledgments
(messages) for each submission.
Acknowledgment 1 comes from the ESG
and indicates your submission was
received. Acknowledgment 2 is sent by
the ESG and indicates the submission
reached CDRH. CDRH sends
Acknowledgment 3 and notifies you
whether your submission was
successfully loaded into CDRH’s
adverse event database or the
submission contained errors (specified
in the acknowledgment) during
validation and loading. If your
submission contained errors, the errors
need to be corrected and the corrected
reports resent.
II. Description of the Proposed Rule
A. How Would the Rule Address
Submission of Reports in Electronic
Format?
This rule would revise § 803.12 to
require that manufacturers, importers,
and user facilities submit postmarket
MDRs to the agency in an electronic
format that FDA can process, review,
and archive. Under the proposal, FDA
will periodically issue information on
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file formats, preparation and
organization of files, media, method of
transmission, and other relevant
technological specifications for
providing reports in an electronic
format that FDA can process, review,
and archive. Proposed new § 803.23
would direct reporters to the agency’s
Web site to find the most updated
relevant information. Reports between
manufacturers, importers, and user
facilities would not be subject to the
requirement of submission in electronic
format, and may be in any format the
recipient can read.
The rule would make conforming
changes throughout part 803 to reflect
the proposed requirement to submit
reports to FDA in electronic format.
These changes include removing
§ 803.11, which currently addresses
obtaining paper forms, and removing
§ 803.14, which currently provides for
voluntary electronic submission of
reports with FDA consent. The proposal
would amend § 803.19, which already
addresses exemptions or variances from
any of the requirements of part 803, to
specifically address exemption or
variance from the requirement to submit
reports to FDA in electronic format.
Other changes include removing
references to ‘‘electronic equivalent[s]
approved under § 803.14’’ from
§§ 803.13, 803.30, 803.33, 803.40, and
803.53, and updating wording in
§ 803.20 and 803.56 to be more
consistent with the fact that reports will
not be submitted on paper (and thus, for
example, would no longer have a front
and back).
If this proposed rule becomes final,
manufacturers, importers, and user
facilities would be required to begin
submitting medical device reports to the
agency in electronic format no later than
1 year from the date of publication of a
final rule. After the effective date, the
agency would not accept MDRs
submitted on paper copies of the FDA
Form 3500A, or in electronic formats
other than those identified as ones that
FDA can process, review, and archive in
information provided in conjunction
with this rule, unless the agency had
granted an exemption or variance as
provided for in § 803.19.
1. How Would the Reporting
Requirements for Manufacturers Change
With Respect to Electronic Format?
The rule would amend §§ 803.50(a),
803.53, and 803.56 to require
submission of information required by
§§ 803.52, 803.53, and 803.56 in
electronic format in accordance with
§ 803.12(a).
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2. How Would the Reporting
Requirements for Importers Change
With Respect to Electronic Format?
The proposed rule amends § 803.40(a)
to require submission to FDA of
information required by § 803.42 in
electronic format in accordance with
§ 803.12(a). The proposed electronic
format requirement does not extend to
importer reports submitted to device
manufacturers, which may be in any
format that the recipient can read.
3. How Would the Reporting
Requirements for User Facilities Change
With Respect to Electronic Format, and
How Would Annual Report
Requirements be Affected?
The proposed rule amends § 803.30(a)
to require submission to FDA of
information required by § 803.32 in
electronic format in accordance with
§ 803.12(a). The amendment does not
impose mandatory electronic format
requirements on user facility reports
submitted to device manufacturers,
which may be provided in any format
the recipient can read.
The proposed rule also makes certain
changes to § 803.33, addressing user
facility annual reports. Under the
proposed rule, user facilities will
continue to submit annual reports on
the paper FDA Form 3419. Because the
proposal to require submission of
individual adverse events reports in
electronic format calls for amendments
to § 803.12 and for removal of §§ 803.11
(indicating how to obtain paper forms)
and 803.14 (addressing voluntary
electronic submissions), FDA is
proposing to amend § 803.33 to specify
where to obtain the FDA Form 3419,
where to submit completed reports
under that section, and to remove
references to § 803.14.
4. How Would the Requirement to
Submit Reports in Electronic Format
Affect Recordkeeping Requirements?
Section 803.18 of the regulation
addresses requirements for establishing
and maintaining MDR files or records
for manufacturers, user facilities, and
importers. FDA is proposing to amend
§ 803.18(b)(ii) to require that MDR files
contain copies of all reports submitted
under part 803, whether paper or
electronic. As under the current
regulations, under the proposal,
regulated entities may choose to
maintain required records either in hard
copy, by printing out reports submitted
in electronic format, or in electronic
form. (For information regarding FDA’s
current thinking and enforcement policy
with regard to requirements for
maintaining electronic records, see 21
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42207
CFR part 11 and the agency guidance
document, ‘‘Guidance for Industry: Part
11, Electronic Records; Electronic
Signatures—Scope and Application,’’
available at https://www.fda.gov/
downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
ucm072322.pdf5667fnl.pdf.). FDA is
also proposing to add § 803.18(b)(1)(iii)
to require the retention of all
acknowledgments FDA sends the
manufacturer, importer, or user facility
when reports are submitted in electronic
format, which will indicate the timing
and success of submission.
B. How Would I Submit MDRs in
Electronic Format?
As noted previously, if the proposed
rule is finalized, manufacturers,
importers, and user facilities will be
required to submit most MDRs to the
agency in an electronic format that FDA
can process, review, and archive. In
order to best accommodate
technological changes, FDA expects to
issue information on how to prepare
and submit MDRs to the agency in a
way that would satisfy the requirements
of this proposed rule. The most specific
and updated information about how to
create, format, and transmit reports,
using the CeSub software (designed for
low volume reporting) or the HL7 ICSR
(designed for high volume reporting), is
provided on the agency’s Web site, at
the address provided in proposed
§ 803.23. The agency will make every
effort to maintain backwards
compatibility when implementing
changes to the systems and formats for
electronic submission. When backwards
compatibility is not possible, the agency
will provide public notice with a
duration commensurate with the
complexity of the change.
C. How Can a Medical Device
Manufacturer, Importer, or User Facility
Obtain a Variance Regarding the
Requirement to Submit a Report in
Electronic Format?
Under proposed § 803.19, a
manufacturer, importer, or user facility
may submit a written request to FDA
seeking a variance of the § 803.12
requirement to submit reports to the
agency in an electronic format that the
agency can process, review, and archive.
Written requests must contain the
reason(s) why the reporting entity
requires a variance and for how long the
variance is needed. FDA anticipates
receiving few variance requests because
of the availability of the Internet and the
commercial availability of digital
certificates as well as FDA’s free CeSub
Internet software. Under the proposal, if
FDA grants a variance, the
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manufacturer, importer, or user facility
would be required to submit MDRs as
specified by FDA in the letter
authorizing the variance.
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D. What Other Changes Are Being
Proposed?
The proposed rule would also codify
the following modifications:
1. FDA proposes to remove the
definition of ‘‘Five-day report’’ in
§ 803.3, which merely referred to a
report submitted under § 803.53 (the
only provision of the regulation in
which the term appears), using the FDA
Form 3500A or ‘‘an electronic
equivalent approved under § 803.14.’’
Because this definition is not necessary,
FDA proposes to remove it.
2. FDA proposes to amend §§ 803.32,
803.42, and 803.52 to make minor
wording changes and corrections to
these sections to reflect modifications
already made to FDA Form 3500A and
its instructions, with OMB approval
under the PRA. For example, section
303 of the Medical Device User Fee and
Modernization Act of 2002 (Public Law
107–250) required FDA to modify the
forms to facilitate reporting of MDRs
involving single-use devices that have
been reprocessed for reuse (see 69 FR
7491, February 17, 2004). FDA is
proposing to amend §§ 803.32, 803.42,
and 803.52 to reflect the addition to the
FDA Form 3500A of these two questions
concerning whether the device is a
single use device that has been
reprocessed and reused on a patient and
the name and address of the
reprocessor.
FDA is also proposing to change
§§ 803.32(b)(4), 803.42(b)(4), and
803.52(b)(4) from ‘‘date of report by the
initial reporter’’ to ‘‘date of this report.’’
This change would make part 803
consistent with the way that other FDA
Centers interpret FDA Form 3500A,
Block B4 and how Block B4 appears on
FDA Form 3500A. Finally, FDA is also
proposing to make other minor updates
to §§ 803.32(c), 803.42(c), and 803.52(c)
and (e) to reflect the changes already
made to the forms and instructions,
including a reference to the product
code and PMA/510(k) number.
E. When Would the Rule Become
Effective?
FDA proposes that any final rule that
issues based on this proposal become
effective 1 year after the date the final
rule publishes in the Federal Register.
III. What Is the Legal Authority for This
Rule?
FDA’s legal authority to amend its
regulations governing the submission of
postmarket medical device adverse
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event reports for medical devices
derives from 21 U.S.C. 352, 360, 360i,
360j, 371, and 374.
IV. Is There an Environmental Impact?
The agency has determined under 21
CFR 25.30(h) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
V. Analysis of Impacts
FDA has examined the impacts of the
proposed rule under Executive Order
12866 and the Regulatory Flexibility Act
(5 U.S.C. 601–612), and the Unfunded
Mandates Reform Act of 1995 (Public
Law 104–4). Executive Order 12866
directs agencies to assess all costs and
benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). This proposed rule
has been determined to be a significant
regulatory action.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because we lack information on
the electronic submission capabilities of
all the firms potentially affected by this
proposed rule we have not proposed to
certify that the proposed rule would not
have a significant economic impact on
a substantial number of small entities.
We request commenters to submit such
information in their comments.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $133
million, using the most current (2008)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this proposed rule to result in any 1year expenditure that will meet or
exceed this amount.
The purpose of this proposed rule is
to require the submission of MDRs in an
electronic format the agency can
process, review, and archive. It would
affect all persons subject to medical
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Fmt 4702
Sfmt 4702
device reporting under part 803, which
includes medical device manufacturers,
device importers, and user facilities.
The proposed rule is part of a greater
agency initiative to adopt electronic
technologies to improve the quality of
our operations and increase the
efficiency of our resources. The rule
would reduce FDA’s current costs
associated with processing medical
device reports (or MDRs) that are
received on the paper FDA Form 3500A.
By receiving MDRs electronically, FDA
would be able to access the adverse
event information more quickly and also
eliminate potential data entry errors that
could occur during input transcription
of the information from the paper FDA
Form 3500A reports into our electronic
medical device adverse event reporting
database.
After considering various alternatives,
FDA determined that without this
regulation, the agency will need to
maintain adequate resources to continue
to convert paper 3500A MDRs to
electronic MDR records until all
manufacturers, importers, and user
facilities voluntarily adopted the
proposed electronic submission format,
possibly years in the future.
A. Benefits
The major benefit of this proposed
rule would be to public health because
the agency would have quicker access to
the medical device adverse event
reports information and thus could
more quickly identify and act on any
medical device problems. Currently,
FDA receives 100,000 initial MDRs
annually on the paper FDA Form
3500A, which are manually entered into
the FDA database. FDA receives an
additional 110,000 supplemental reports
each year that are also submitted on the
paper FDA Form 3500A and need to be
processed and entered into the FDA
database. It can take from 3 days to more
than 6 months before an MDR submitted
on a paper copy of the FDA Form 3500A
may be available for analysis in the
Manufacturer and User Device
Experience database (MAUDE). With a
standardized electronic format, medical
device reports would become available
for analysis as soon as they are
processed into MAUDE. With a
reduction in the time to manually enter
the MDRs into the MAUDE database,
analysis and action, including feedback
to manufacturers and consumers, could
be taken sooner with a corresponding
benefit to public health.
The public health benefits would be
supplemented with operating cost
reductions within FDA. Assuming the
number of MDRs remains fairly constant
over time, electronic reporting would
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save the agency about $1.25 million
annually in data entry costs, which is
about one-half of our current data entry
contract.
B. Costs
There are about 18,000 medical
device manufacturers and importers
identified in FDA’s medical device
registration database and approximately
38,500 user facilities identified in the
42209
2002 U.S. Economic Census that would
be affected by the proposed rule (for a
total of 56,500 manufacturers,
importers, and user facilities) (Census,
2002). Table 1 shows the estimated
numbers of firms and establishments in
the affected industries.
TABLE 1.—AFFECTED FIRMS AND ESTABLISHMENTS
North American Industry Classification System
(NAICS) Code
Description
No. of Firms
No. of Establishments
Various
Devices
18,000
8,000
622
Hospitals
3,800
6,342
6231
Nursing care facilities
7,826
15,480
6214
Outpatient care centers
11,125
23,912
6215
Medical and diagnostic laboratories
5,736
9,844
6216
Home health care services
9,987
15,016
56,474
88,594
Total
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The incremental cost of changing to
electronic submissions for each affected
entity would vary by the size, type, and
corporate structure of the firm, as well
as by its current electronic submission
capability. The total costs associated
with this proposed rule would include
one-time set-up costs and annual
operating costs.
1. One-Time Costs
One-time costs would be the sum of
the costs of:
• Rewriting standard operating
procedures (SOPs) and training the
appropriate personnel,
• Installing and validating either the
installation of CDRH’s CeSub Web
interface software or the programming
and configuration of a computer system
to transmit reports directly to the FDA
ESG using the HL7 ICSR, and
• Acquiring the electronic digital
certificate required by the FDA ESG.
a. Rewriting SOPs and training
personnel. All entities affected would
need to update their SOPs to include the
electronic submission requirement. For
medical device manufacturers,
importers, and hospitals, we estimate
that it would require about 10 hours to
make the modifications and train the
appropriate people on the new
procedures. For the other user facilities,
we assume that the corporate or regional
offices would have the major
responsibility for medical device
reporting and thus the SOPs for these
individual entities would require less
time to modify. For this analysis we
estimated that 55 percent of the other
user facilities would require about 10
hours to modify their SOPs and the
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remaining 45 percent would require
about 2 hours.1 The estimated one-time
incremental cost for updating SOPs,
assuming an average wage rate of $52
per hour,2 (Bureau of Labor Statistics
(BLS), 2006) is about $34.1 million
[((18,000 medical device manufacturers
and importers + 6,300 hospitals) x 10
hours) + ((0.45 x 2 hours + 0.55 x 10
hours) x 64,500 other user facilities) x
$52/hour].
b. Setting up systems for submission.
MDRs would be submitted through the
FDA ESG using one of two methods:
The CDRH CeSub software or the HL7
ICSR. Because most entities are small
and submit few if any MDRs annually,
we assume they would probably use the
CDRH CeSub software, which allows for
the submission of one MDR at a time. To
comply using this submission method,
manufacturers, importers, and user
facilities would need high-speed
Internet connections and would have to
download and install up to three free
software programs, validate the
installation, and train the appropriate
personnel on the new procedures.
Entities that have dedicated information
technology (IT) staff would be able to
install and validate the installation
themselves. Smaller manufacturers,
importers, and user entities would
1 Percentages are based on the ratio of firms to
establishments from 2002 Census of Manufactures
data.
2 $52 per hour wage is based on BLS
Occupational Employment and Wages, May 2006,
for Medical and Health Service Managers, Standard
Occupational Classification 11–19111. Forty
percent was added to the mean hourly wage of
$37.09 to account for benefits and the total was
rounded to the nearest whole number.
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Fmt 4702
Sfmt 4702
probably choose to hire an outside
contractor for the installation and its
validation.
We do not have data on the amount
of time required to install and validate
the installation of the software or the
percentage of entities that might need to
contract out the installation. For this
analysis, we assumed it would take an
entity 8 to 16 hours to install and
validate the installation of CDRH’s
CeSub software and install, if necessary,
Java Runtime Edition software and Java
security policy files for their Internet
browser. This estimate also includes the
time required to notify FDA, run a test
submission through the FDA ESG, and
to train the appropriate staff to use the
new program. We are also assuming that
almost all medical device
manufacturers, importers, and all user
facilities would use this method to
submit MDRs. Using an average wage of
$46.50 for computer and mathematical
occupations3 (BLS 2006), we estimate
the cost to install and use the software
to be between $21.0 million and $41.7
million [(8 hours x $46.50 wage) x
(38,500 user facilities + 18,000
manufacturers and importers) to (16
hours x $46.50 wage) x (38,500 user
facilities + 18,000 manufacturers and
importers)].
Entities that submit a large number of
MDRs each year may choose to use the
HL7 ICSR method to submit the reports.
3 BLS Occupation Employment and Wages, May
2006, by occupation, for all industries (https://
www.bls.gov). Wage ($46.50) includes mean hourly
wage of $33.22 for Standard Occupational
Classification 15–0000, computer and mathematics
occupations, all industries; we add 40 percent to
account for benefits.
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This method allows for the batch
submission of multiple MDRs at faster
transmission rates. We do not know at
what threshold of reporting it becomes
cost effective for an entity to submit
medical device reports using this
method. An analysis of FDA submission
data for a 6-year period indicated that
about 20 large medical device
manufacturers submit 500 or more
MDRs each year and about 85 submit
close to 100 medical device reports per
year. We assumed that the actual
number of entities using the HL7 ICSR
would fall somewhere within this range
(20 to 85). We also assumed that only
entities that have existing infrastructure
to support HL7 ICSR transmissions
would choose this method to submit
MDRs. We estimated that it would take
about 50 hours to set up their gateway
to be compatible with the agency’s
system. Using the wage $46.50, the onetime cost for establishing HL7 ICSR
submission capabilities would range
between $50 thousand and $200
thousand [($46.50 x 50 hours) x 20
and user facilities affected by this
proposed rule may have to hire outside
expertise to install and validate the
software installation to comply with the
proposed requirements.
Table 2 summarizes the estimated
one-time costs by type of cost for this
proposed rule by cost and type of
manufacturers, importers, and user
entities. The estimate of the total onetime costs for all manufacturers,
importers, and user facilities ranges
from $58.6 million to $79.7 million.
Much of the cost involves acquiring the
electronic certificate for the capability to
submit any regulatory document to the
FDA, including installation and
validation of the CeSub software or to
establish HL7 ICSR capabilities.
Therefore, manufacturers, importers,
and user facilities that are not already
making electronic submissions of any
kind to the agency if this proposed rule
becomes final would incur these total
costs.
entities) and ($46.50 x 50 hours) x 85
entities)].
c. Electronic certificates. All entities
would need an electronic certificate to
submit any electronic regulatory
document to the FDA ESG. The
electronic certificate identifies the
sender and serves as an electronic
signature. Entities that have not
submitted any electronic documents to
the agency would incur a one-time cost
to acquire the certificate and recurring
costs to keep the certificate active as a
result of this proposed rule. The
certificates cost about $20 and are valid
for 1 year. We assume that the search
and transactions costs involved in the
initial acquisition of the certificate
doubles the cost of the certificate to a
total of $40 for the first year, half of
which would be setup costs. If all
entities needed to acquire electronic
certificates, the one-time search and
acquisition costs would be $1.1 million
($20 acquisition cost x 56,500 entities).
In addition to the costs we have
estimated, manufacturers, importers,
TABLE 2.—SUMMARY OF ONE-TIME COSTS BY INDUSTRY ($ MILLION)
Industry
Modifying
SOPs
Install and validate CeSub
software
low
9.4
6.7
13.4
User Facility
26.9
14.3
36.3
21.0
42.0
low
Total
Acquiring ecertificate
high
28.6
Total
16.6
23.4
0.8
42.0
56.3
1.2
58.6
79.7
6.9
9.3
Annualized at 7 percent over 10 years
8.3
11.4
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0.05
facilities need to acquire electronic
certificates, the annual cost would be
$1.7 million ($30 acquisition certificate
renewal and acquisition cost x 56,500
entities).
b. High-speed Internet access. Entities
would also need high-speed Internet
access to use either of the submission
methods. A 2004 study of small
businesses sponsored by the Small
Business Administration (SBA) found
that essentially all small firms had
Internet access and about 50 percent
had high-speed Internet access (Pociask,
2004). The average cost of high speed
access was about $40 per month more
than dial-up access. Because the average
cost of Internet access has been going
down over time, we estimate that by the
time this proposed rule would be made
final, about 75 percent of device and
user facilities would have high speed
access. The average annual recurring
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Sfmt 4702
0.2
high
0.4
2. Annual Costs
The annual costs of this proposed rule
would include the costs of:
• Maintaining certificates and
• High-speed Internet access.
a. Maintaining electronic certificates.
Manufacturers, importers, and user
facilities would bear the cost to
maintain the electronic certificate that
identifies the sender. In addition to
having to renew the certificate on a
regular basis, those entities who have
not submitted MDRs would also have to
ensure they are capable of transmitting
electronic MDRs to FDA should such a
report submission be necessary. To add
these costs to the cost of the certificate
itself, we assume that entities would
incur an additional annually recurring
cost equal to one-half the price of the
certificate ($10), for a total annually
recurring cost of $30. If all
manufacturers, importers, and user
0.05
low
Annualized at 3 percent over 10 years
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Medical Device
high
Gateway to gateway
0.2
increase in cost for high speed Internet
access for the remaining 25 percent of
the entities would be $6.8 million (($40
x 12 months) x (0.25 x (18,000
manufacturers and importers + 38,500
user facilities))).
Table 3 shows the annual costs of the
proposed rule. As with the one-time
costs, only entities not making
electronic regulatory document
submissions of any kind to the agency
if this proposed rule becomes final
would incur all these costs. There
would be no change in the actual time
required to research and prepare the
MDRs, nor would there be any
additional reporting requirements as a
result of this proposed rule.
Manufacturers, importers, and user
facilities that maintain paper FDA Form
3500A records for their internal MDR
files own use could still do so under the
proposed rule.
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42211
TABLE 3.—SUMMARY OF ANNUAL COSTS BY INDUSTRY ($ MILLION)
Acquiring electronic
certificate
High-speed Internet
access
Medical Device
0.5
2.2
User Facility
1.2
4.6
Total
1.7
6.8
Industry
Cost savings: We estimate a modest
industry savings of about $3.2 million
annually because electronic submission
should reduce the time it takes to
submit documents. It should be noted
that the savings accumulate to firms
submitting MDRs; firms that submit
very few or no MDRs would not realize
any savings.
C. Summary of Benefits and Costs
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The principal benefit of this proposed
rule would be the public health benefits
associated with more rapid processing
and analysis of the 100,000 initial
individual MDRs currently submitted to
FDA on a paper FDA Form 3500A. In
addition, requiring electronic
submission of MDRs is expected to
reduce FDA annual operating costs by
$1.25 million and generate industry
savings of about $3.2 million.
The total one-time cost for modifying
SOPs and establishing electronic
submission capabilities is estimated to
range from $58.6 million to $79.7
million. Annually recurring costs
totaled $8.5 million and include
maintenance of electronic submission
capabilities, including renewing the
electronic certificate, and for some
entities the incremental cost to maintain
high-speed Internet access. The total
annualized cost of the proposed rule,
assuming a 7-percent discount rate over
10 years, would be from $16.8 million
to $19.9 million ($15.4 million to $17.8
million at a 3-percent discount rate). We
request comment on the accuracy and
completeness of the assumptions used
to estimate the costs of this proposed
rule. For example, we invite comment
on our use of a 10-year time horizon and
whether a shorter or a longer horizon
would be more appropriate to express
the social costs of this proposed rule.
D. Alternatives Considered
During the development of this
proposed rule, we considered a number
of alternative approaches. The first was
to allow manufacturers, importers, and
user facilities to voluntarily submit
MDRs electronically. Because our
experience has shown that a number of
medical device firms and user facilities
would resist changing their procedures
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for a long period of time, we would not
attain the benefits of standardized
formats and quicker access to medical
device adverse event data. The FDA, for
example, would have to maintain
contracts to handle the input of
information from both written and
electronic MDRs. A voluntary system,
therefore, would fail to achieve the goals
of this proposed rule.
Another alternative was to allow
small entities more time to comply with
the electronic submission requirements.
This alternative would allow small
entities to delay compliance. Under this
alternative, we would not receive the
full data-entry savings from requiring
electronic submissions or all the
benefits of quicker access to these
reports. Because so many device
companies are small entities, this
approach would significantly postpone
the benefits the rule is intended to
confer. Moreover, as shown in the
following section, the estimated
incremental costs per small entity from
the proposed rule are small, so the cost
reduction per small entity from delayed
compliance would also be small.
E. Regulatory Flexibility Analysis
The SBA defines a small medical
device manufacturer as having fewer
than 500 employees. Based on data from
U.S. Census, about 98 percent of device
firms affected by this proposed rule are
considered small entities, and have an
average value of shipments of about $9.0
million.4 Businesses in the health care
industry are classified as small if their
revenues are below a certain level.
Hospitals are small if their total revenue
falls below $25 million and the other
user facilities are considered small if
their revenues are below $10 million.
U.S. Census data indicates that about 87
percent of the user facilities are
4 U.S. Census Bureau, 2002 Economic Census,
Manufacturing Industry Series, Industry Statistics
by Employment Size for NAICS codes: 334510,
339112, 339113, 339114, and 339115
(www.census.gov).
5 U.S. Census Bureau, 2002 Economic Census,
Release Date 11/22/2005, Sector 62: Health Care
and Social Assistance: Subject Series—
Establishment and Firm Size: Receipts/Revenue
Size the United States for NAICS 622, 6231, 6214,
6215, and 6216 accessed via American Fact Finder
(www.census.gov).
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Sfmt 4702
Total
8.5
classified as small and have a weighted
average revenue of about $3.3 million.5
However, very few user facilities submit
MDRs in any given year. While this
proposed rule will now require those
reports submitted to the agency to be in
electronic format, the content of a report
is not being changed from that already
addressed on the current FDA Form
3500A. The average costs for these
manufacturers, importers, and user
facilities are listed in table 4. The
average total annualized cost per small
entity, assuming a 7-percent discount
rate over 10 years, would range from
$581 to $693; at a 3-percent discount
rate, average annualized costs would
range from $568 to $661. These costs
represent less than 0.1 percent of
revenues for medical device firms and
less than 0.1 percent of revenues for
user facilities.
We considered two possible
alternatives for regulatory relief for
small businesses. As described above,
one regulatory alternative would be
longer compliance times for small
entities. We would not receive the full
data-entry savings from requiring
electronic submissions or all the
benefits of quicker access to these
reports. Because so many device
companies are small entities, this
approach would significantly postpone
the benefits the rule is intended to
confer. Moreover, as shown above, the
estimated incremental costs per small
entity from the proposed rule are small,
so the cost reduction per small entity
from delayed compliance would also be
small.
In addition, we considered proposing
a waiver to the electronic submission
requirement for small firms that can
demonstrate an economic hardship.
Because the estimated incremental costs
per small entity from the proposed rule
are small, the cost reduction per small
entity from a waiver would also be
small.
We ask for comments on both of these
options for regulatory relief for small
entities.
While the estimated costs per affected
entity are low, FDA does not have
adequate information on the electronic
capabilities of all of the firms affected
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by this proposed rule and has made
many assumptions to derive these
estimate used in this analysis, therefore
we do not propose to certify that this
proposed rule would not have a
significant economic impact on a
substantial number of small entities.
FDA requests comment on this issue.
TABLE 4.—INCREMENTAL COMPLIANCE COSTS PER SMALL ENTITY
One-Time
Costs
low
Total
Annualized
Annually
Recurring
high
low
Rewriting SOPs
104
520
Software Installation and validation of installation
372
high
744
Acquiring Electronic Certificate
40
Maintaining submission capabilities
30
Upgrade Internet Access
480
581
693
3 percent discount rate
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7 percent discount rate
568
661
VI. Paperwork Reduction Act of 1995
This proposed rule contains
information collection provisions that
are subject to review by OMB under the
PRA (44 U.S.C. 3501–3520). A
description of these provisions is given
in this document with an estimate of the
annual reporting and recordkeeping
burden. Included in the estimate is the
time for reviewing instructions,
searching existing data sources,
gathering and maintaining the data
needed, and completing and reviewing
each collection of information.
FDA invites comments on these
topics: (1) Whether the proposed
collection of information is necessary
for the proper performance of FDA’s
functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
Title: Medical Device Reporting
Description: In accordance with the
proposed Medical Device Reporting
regulation, medical device
manufacturers, importers, and user
facilities would be required to submit
MDRs to FDA, to maintain records, and
may also seek exemption or variance
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from these requirements. FDA is also
proposing to amend §§ 803.32, 803.42,
and 803.52 to make minor wording
changes and corrections to these
sections to reflect modifications already
made to FDA Form 3500A and its
instructions. Manufacturers, importer,
and user facilities are currently
submitting paper MDR reports on FDA
Form 3500A. The existing information
collection for part 803 is approved
under OMB control number 0910–0437.
The changes to the burden associated
with this proposed rule are described
below and have been sent to OMB as a
revision to OMB control number 0910–
0437 for review under section 307(d) of
the PRA.
Section 519(a)(1) of the act (21 U.S.C.
360i(a)(1)) requires every manufacturer
or importer to report ‘‘whenever the
manufacturer or importer receives or
otherwise becomes aware of information
that reasonably suggests that one of its
marketed devices—
(A) may have caused or contributed to
a death or serious injury, or
(B) has malfunctioned and that such
device or a similar device marketed by
the manufacturer or importer would be
likely to cause or contribute to a death
or serious injury if the malfunction were
to recur * * *’’
Section 519(b)(1)(A) of the act
requires ‘‘whenever a device user
facility receives or otherwise becomes
aware of information that reasonably
suggests that a device has or may have
caused or contributed to the death of a
patient of the facility, the facility shall,
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Sfmt 4702
as soon as practicable but not later than
10 working days after becoming aware
of the information, report the
information to the Secretary and, if the
identity of the manufacturer is known,
to the manufacturer of the device.’’
Section 519(b)(1)(B) of the act requires
‘‘whenever a device user facility
receives or otherwise becomes aware of:
(i) information that reasonably suggests
that a device has or may have caused or
contributed to the serious illness of, or
serious injury to, a patient of the facility
* * *, shall, as soon as practicable but
not later than 10 working days after
becoming aware of the information,
report the information to the
manufacturer of the device or to the
Secretary if the identity of the
manufacturer is not known.’’
Complete, accurate, and timely
adverse event information is necessary
for the identification of emerging device
problems so the agency can protect the
public health under section 519 of the
act. FDA is requesting approval for the
information collection requirements
contained in part 803.
Description of Respondents:
Manufacturers and importers of medical
devices and device user facilities.
Device user facility means a hospital,
ambulatory surgical facility, nursing
home, outpatient diagnostic facility, or
outpatient treatment facility as defined
in § 803.3, which is not a physician’s
office (also defined in § 803.3).
The total annual estimated burden
imposed by this collection of
information is 21,525 hours annually.
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TABLE 5.—ESTIMATED ANNUAL REPORTING BURDEN
21 CFR
Section
FDA
Form No.
No. of
Respondents
803.19
Annual Frequency
Per Response
Total Annual
Responses
Hours per
Response
Total
Hours
55
4
220
1
220
411
2
822
0.33
271
411
1
411
1
411
803.40 and 803.42
44
20
880
0.33
290
803.50 and 803.52
1,304
58
75,632
0.11
8,248
803.56
1,200
48
57,600
0.10
5,760
803.30 and 809.32
803.33
3419
Total
15,200
TABLE 6.—ESTIMATED ANNUAL RECORDKEEPING BURDEN
21 CFR
Section
No. of
Respondents
803.17
Frequency per
Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
1,677
Total
1,677
3.3
5,534
527
803.18 (a) to (d)
1
1
527
1.5
791
2,204
The approved MDR reporting and
recordkeeping burden for paper
submissions is 138,271 hours. This
proposed rule reporting and
recordkeeping burden for electronic
submissions is 21,525 hours, a decrease
of 123,071 hours. Based on an average
wage rate of $46.50 per hour, the total
cost to respondents associated with
these reporting and recordkeeping
burdens is $1,000,913. An explanation
2,204
for the burden decrease is provided
below.
A. Reporting Requirements
The number of respondents for each
Code of Federal Regulations (CFR)
section in table 5 is based upon the
number of respondents entered into
FDA’s internal databases. FDA estimates
that electronic submission will decrease
the burden associated with §§ 803.19,
803.30, 803.32, 803.40, 803.50, 803.52,
and 803.56. We believe electronic
6,325
submission will neither increase nor
decrease burden associated with
§ 803.33, which we estimate will take 1
hour. We believe § 803.19 will take 1
hour, while §§ 803.30, 803.32, 803.40,
and 803.42 will take 20 minutes.
Sections 803.50 and 803.52 will take 7
minutes. Section 803.56 will take 6
minutes. The following table
summarizes our burden estimates and
how we believe they will change due to
electronic submission.
TABLE 7.—ESTIMATED REPORTING BURDEN PROGRAM CHANGE
Hours per response
under current paper
submission process
21 CFR Section
Hours per response
as result of electronic
submission
Burden Change
3
1
803.30 and 809.32
1
0.33
803.33
1
1
803.40 and 803.42
1
0.33
Reduction (.66 hours)
803.50 and 803.52
1
0.11
Reduction (.89 hours)
803.56
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803.19
1
0.10
Reduction (.90 hours)
As previously described, there are two
reporting options. The first one is CeSub
for low volume reporters and the second
one is HL7 ICSR for high volume
reporters. We are basing our hours per
response for both systems on FDA’s
experience using the two options.
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B. Recordkeeping Requirements
The number of respondents for each
CFR section in table 6 is based upon the
number of respondents entered into
FDA’s internal databases. The agency
believes that the majority of
manufacturers, user facilities, and
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Fmt 4702
Sfmt 4702
Reduction (2 hours)
Reduction (.66 hours)
no change
importers have already established
written procedures to document
complaints and information to meet the
MDR requirements as part of their
internal quality control system. The
following table summarizes our burden
estimates and how we believe they will
change due to electronic submission.
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TABLE 8.—ESTIMATED RECORDKEEPING BURDEN PROGRAM CHANGE
Hours per response
under current paper
submission process
Hours per response
as result of electronic
submission
10
21 CFR Section
3.3
Reduction (7.7 hours)
1.5
No change
803.17
803.18 (a) to (d)
1.5
C. Total Annual Cost Burden
As stated earlier, the cost to
respondents for these reporting and
recordkeeping requirements is
$1,000,913. In addition, the conversion
from paper to electronic submissions
will result in capital costs, both onetime costs as well as annual costs, as
discussed earlier in this proposed rule
in the economic analysis. One-time
capital costs include the cost to modify
reporting systems, installing and
validating CeSub software, installing
gateway to gateway submission
capabilities, and acquiring e-certificates
and have been estimated to range from
a low of $58.6 million to a high of $79.7
million. Once the procedures have been
modified, there is an operating and
maintenance cost to renew the digital
certificate and maintain high-speed
internet access, which have been
estimated cost $8.5 million each year.
Burden estimates are based on reports
processed between July 1, 2005, and
June 30, 2006, with the existing medical
device adverse event reporting program.
In compliance with the PRA, the
agency has submitted the information
collection provisions of this proposed
rule to OMB for review. Interested
persons are requested to send comments
regarding information collection to
OMB (see the DATES and ADDRESSES
sections of this document).
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VII. Federalism
FDA has analyzed this proposed rule
in accordance with the principles set
forth in Executive Order 13132. FDA
has determined that this rule does not
contain policies that have federalism
implications as defined in the order
and, consequently, a federalism
summary impact statement is not
required.
VIII. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
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heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IX. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site addresses, but is not
responsible for any subsequent changes
to the Web site after this document
publishes in the Federal Register.)
1. U.S. Census Bureau, 2002 Economic
Census Industry Series: NAICS Code 62,
Health Care and Social Assistance (https://
www.census.gov). Total is the sum of firms in
NAICS 622, 6231, 6214, 6215, and 6216.
2. BLS Occupational Employment and
Wages May 2005 for Medical and Health
Service Managers, Standard Occupational
Classification, 11–19111.
3. Pociask, Steven, A Survey of Small
Businesses’ Telecommunications Use and
Spending, SBA Office of Advocacy contract
number SBA–HQ–02–M–0493, March 2004.
List of Subjects in 21 CFR Part 803
Imports, Medical devices, Reporting
and recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, FDA proposes to
amend part 803 to read as follows:
PART 803—MEDICAL DEVICE
REPORTING
1. The authority citation for 21 CFR
part 803 continues to read as follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j,
371, 374.
§ 803.3
[Amended]
2. Amend § 803.3 by removing the
definition for ‘‘Five-day report’’.
§ 803.11
[Removed]
3. Remove § 803.11.
4. Revise § 803.12 to read as follows:
§ 803.12 How do I submit reports and
supplements?
(a) Manufacturers, user facilities, and
importers must submit initial and
supplemental reports to FDA in an
electronic format that FDA can process,
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Burden Change
review, and archive. FDA will provide
and update information on how to
provide the electronic submission (e.g.,
preparation and organization of files,
file formats, media and method of
transmission).
(b) If you are confronted with a public
health emergency, this can be brought to
FDA’s attention by contacting the FDA
Office of Emergency Operations (HFA–
615), Office of Crisis Management,
Office of the Commissioner, at 301–443–
1240, followed by the submission of an
e-mail to
emergency.operations@fda.hhs.gov.
Note: This action does not satisfy your
obligation to report under part 803.
(c) You may submit a voluntary
telephone report to the MEDWATCH
office at 800–FDA–1088. You may also
obtain information regarding voluntary
reporting from the MEDWATCH office
at 800–FDA–1088. You may also find
the voluntary MEDWATCH 3500 form
and instructions to complete it at https://
www.fda.gov/Safety/MedWatch/
HowToReport/DownloadForms/
default.htm.
5. Revise § 803.13 to read as follows:
§ 803.13 Do I need to submit reports in
English?
Yes. You must submit all reports
required by this part in English.
§ 803.14
[Removed]
6. Remove § 803.14.
7. Amend § 803.18 by revising
paragraph (b)(1)(ii) and adding
paragraph (b)(1)(iii) to read as follows:
§ 803.18 What are the requirements for
establishing and maintaining MDR files or
records that apply to me?
*
*
*
*
*
(b)(1) * * *
(ii) Copies of all reports submitted
under this part (whether paper or
electronic), and of all other information
related to the event that you submitted
to us or other entities such as an
importer, distributor, or manufacturer.
(iii) Copies of all electronic
acknowledgments FDA sends you in
response to your electronic submissions.
*
*
*
*
*
8. Amend § 803.19 by revising
paragraphs (b) and (e) to read as follows:
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§ 803.19 Are there exemptions, variances,
or alternative forms of adverse event
reporting requirements?
*
*
*
*
*
(b) If you are a manufacturer,
importer, or user facility, you may
request an exemption or variance from
any or all of the reporting requirements
in this part, including the requirements
of § 803.12(a). You must submit the
request to us in writing at the following
address: MDR Exemption Requests,
Office of Surveillance and Biometrics
(HFZ–530), 1350 Piccard Dr., Rockville,
MD 20850. Your request must include
information necessary to identify you
and the device; a complete statement of
the request for exemption, variance, or
alternative reporting; and an
explanation why your request is
justified. If you are requesting a variance
to the requirement to submit reports to
FDA in electronic format, under
§ 803.12(a), your request should indicate
for how long you would require this
variance.
*
*
*
*
*
(e) If we grant your request for a
reporting modification, you must submit
any reports or information required in
our approval of the modification. The
conditions of the approval will replace
and supersede the regular reporting
requirement specified in this part until
such time that we revoke or modify the
alternative reporting requirements in
accordance with paragraph (d) of this
section, or until the date specified in
our response granting your variance, at
which time, the provisions of this part
will again apply.
9. In § 803.20, revise paragraph (a),
redesignate paragraphs (b) and (c) as
paragraphs (c) and (d), and add new
paragraph (b) to read as follows:
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§ 803.20 How do I complete and submit an
individual adverse event report?
(a) If you are a health professional or
consumer, you may submit voluntary
reports to FDA regarding devices or
other FDA-regulated products using the
FDA Form 3500.
(b) A mandatory electronic
submission from a user facility,
importer, or manufacturer, must contain
the information from the applicable
blocks of FDA Form 3500A. All
electronic submissions must include
information about the patient, the event,
the device, and the ‘‘initial reporter.’’
An electronic submission from a user
facility or importer must include the
information from block F. An electronic
submission from a manufacturer must
include the information from blocks G
and H. If you are a manufacturer and
you receive a report from a user facility
or importer, you must incorporate that
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information in your electronic
submission and include any corrected
or missing information.
*
*
*
*
*
10. Add § 803.23 to read as follows:
§ 803.23 Where can I find information on
how to prepare and submit an MDR in
electronic format?
(a) You may obtain information on
how to prepare and submit reports in an
electronic format that FDA can process,
review, and archive at https://
www.fda.gov/ForIndustry/FDA
eSubmitter/ucm107903.htm.
(b) We may sometimes update
information on how to prepare and
submit reports electronically. If we do
make modifications, we will ensure that
we alert reporters by updating the eMDR
Web page.
11. Amend § 803.30 by revising
paragraphs (a)(1) and (a)(2) to read as
follows:
§ 803.30 If I am a user facility, what
reporting requirements apply to me?
(a) * * *
(1) Reports of death. You must submit
a report to us as soon as practicable but
no more than 10 work days after the day
that you become aware of information,
from any source, that reasonably
suggests that a device has or may have
caused or contributed to the death of a
patient of your facility. You must also
submit the report to the device
manufacturer, if known. You must
submit the information required by
§ 803.32. Reports sent to the agency
must be submitted in accordance with
the requirements of § 803.12(a).
(2) Reports of serious injury. You
must submit a report to the
manufacturer of the device no later than
10 work days after the day that you
become aware of information, from any
source, that reasonably suggests that a
device has or may have caused or
contributed to a serious injury to a
patient of your facility. If the
manufacturer is not known, you must
submit the report to us. You must report
information required by § 803.32.
Reports sent to the agency must be
submitted in accordance with the
requirements of § 803.12(a).
*
*
*
*
*
12. Amend § 803.32 by revising
paragraphs (b)(4) and (c) to read as
follows:
§ 803.32 If I am a user facility, what
information must I submit in my individual
adverse event reports?
*
*
*
*
*
(b) * * *
(4) Date of this report;
*
*
*
*
*
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(c) Device information (Form 3500A,
Block D). You must submit the
following:
(1) Brand name;
(2) Product Code, if known, and
Common Device Name;
(3) Manufacturer name, city, and
state;
(4) Model number, catalog number,
serial number, lot number, or other
identifying number, and expiration date;
(5) Operator of the device (health
professional, lay user/ patient, other);
(6) Date of device implantation
(month, day, year), if applicable;
(7) Date of device explantation
(month, day, year), if applicable;
(8) Whether the device is a single-use
device that was reprocessed and reused
on a patient (Yes, No)?
(9) If the device is a single-use device
that was reprocessed and reused on a
patient (yes to paragraph (c)(8) of this
section), the name and address of the
reprocessor;
(10) Whether the device was available
for evaluation and whether the device
was returned to the manufacturer; if so,
the date it was returned to the
manufacturer; and
(11) Concomitant medical products
and therapy dates. (Do not report
products that were used to treat the
event.)
*
*
*
*
*
13. Revise § 803.33 to read as follows:
§ 803.33 If I am a user facility, what must
I include when I submit an annual report?
(a) You must submit to us an annual
report on FDA Form 3419. You must
submit an annual report by January 1, of
each year. You may obtain this form
from any of the following:
(1) The Consolidated Forms and
Publications Office, Beltsville Service
Center, 6351 Ammendale Rd., Landover,
MD 20705;
(2) FDA, MEDWATCH (HF–2), 5600
Fishers Lane, Rockville, MD 20857,
301–827–7240;
(3) Division of Small Manufacturers,
International, and Consumer Assistance,
Office of Communication, Education,
and Radiation Programs, Center for
Devices and Radiological Health (CDRH)
(HFZ–220), 1350 Piccard Dr., Rockville,
MD 20850, by e-mail:
DSMICA@CDRH.FDA.GOV, or FAX:
301–443–8818; or
(4) On the Internet at https://
www.fda.gov/Safety/MedWatch/How
ToReport/DownloadForms/default.htm.
(b) You must clearly identify your
annual report as such. You must submit
your annual report to FDA, CDRH,
Medical Device Reporting, P.O. Box
3002, Rockville, MD 20847–3002. Your
annual report must include:
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(1) Your CMS provider number used
for medical device reports, or the
number assigned by us for reporting
purposes in accordance with § 803.3;
(2) Reporting year;
(3) Your name and complete address;
(4) Total number of reports attached
or summarized;
(5) Date of the annual report and
report numbers identifying the range of
medical device reports that you
submitted during the report period (e.g.,
1234567890–2007–0001 through 1000);
(6) Name, position title, and complete
address of the individual designated as
your contact person responsible for
reporting to us and whether that person
is a new contact for you; and
(7) Information for each reportable
event that occurred during the annual
reporting period including:
(i) Report number;
(ii) Name and address of the device
manufacturer;
(iii) Device brand name and common
name;
(iv) Product model, catalog, serial and
lot number;
(v) A brief description of the event
reported to the manufacturer and/or us;
and
(vi) Where the report was submitted,
i.e., to the manufacturer, importer, or us.
(c) In lieu of submitting the
information in paragraph (b)(7) of this
section, you may submit a copy of each
medical device report that you
submitted to the manufacturers and/or
to us during the reporting period.
(d) If you did not submit any medical
device reports to manufacturers or us
during the time period, you do not need
to submit an annual report.
14. Revise § 803.40 to read as follows:
CPrice-Sewell on DSKGBLS3C1PROD with PROPOSALS
§ 803.40 If I am an importer, what reporting
requirements apply to me?
(a) Reports of deaths or serious
injuries. You must submit a report to us,
and a copy of this report to the
manufacturer, as soon as practicable,
but no later than 30 calendar days after
the day that you receive or otherwise
become aware of information from any
source, including user facilities,
individuals, or medical or scientific
literature, whether published or
unpublished, that reasonably suggests
that one of your marketed devices may
have caused or contributed to a death or
serious injury. You must submit the
information required by § 803.42.
Reports must be submitted in
accordance with the requirements of
§ 803.12(a).
(b) Reports of malfunctions. You must
submit a report to the manufacturer as
soon as practicable but no later than 30
calendar days after the day that you
VerDate Nov<24>2008
14:17 Aug 20, 2009
Jkt 217001
receive or otherwise become aware of
information from any source, including
user facilities, individuals, or through
your own research, testing, evaluation,
servicing, or maintenance of one of your
devices, that reasonably suggests that
one of your devices has malfunctioned
and that this device or a similar device
that you market would be likely to cause
or contribute to a death or serious injury
if the malfunction were to recur. You
must submit the information required
by § 803.42.
15. Amend § 803.42 by revising
paragraphs (b)(4) and (c) to read as
follows:
§ 803.42 If I am an importer, what
information must I submit in my individual
adverse event reports?
*
*
*
*
*
(b) * * *
(4) Date of this report;
*
*
*
*
*
(c) Device information (Form 3500A,
Block D). You must submit the
following:
(1) Brand name;
(2) Product Code, if known, and
Common Device Name;
(3) Manufacturer name, city, and
state;
(4) Model number, catalog number,
serial number, lot number, or other
identifying number, and expiration date;
(5) Operator of the device (health
professional, lay user/patient, other);
(6) Date of device implantation
(month, day, year), if applicable;
(7) Date of device explantation
(month, day, year), if applicable;
(8) Whether the device is a single-use
device that was reprocessed and reused
on a patient (Yes, No)?
(9) If the device is a single-use device
that was reprocessed and reused on a
patient (yes to paragraph (c)(8) of this
section), the name and address of the
reprocessor;
(10) Whether the device was available
for evaluation and whether the device
was returned to the manufacturer; if so,
the date it was returned to the
manufacturer; and
(11) Concomitant medical products
and therapy dates. (Do not report
products that were used to treat the
event.)
*
*
*
*
*
16. Amend § 803.50 by revising
paragraph (a) introductory text and
paragraph (b)(3) to read as follows:
§ 803.50 If I am a manufacturer, what
reporting requirements apply to me?
(a) If you are a manufacturer, you
must report to us the information
required by § 803.52 in accordance with
the requirements of § 803.12(a), no later
PO 00000
Frm 00033
Fmt 4702
Sfmt 4702
than 30 calendar days after the day that
you receive or otherwise become aware
of information, from any source, that
reasonably suggests that a device that
you market:
*
*
*
*
*
(b) * * *
(3) You are also responsible for
conducting an investigation of each
event and evaluating the cause of the
event. If you cannot submit complete
information on a report, you must
provide a statement explaining why this
information was incomplete and the
steps you took to obtain the information.
If you later obtain any required
information that was not available at the
time you filed your initial report, you
must submit this information in a
supplemental report under § 803.56 in
accordance with the requirements of
§ 803.12(a).
17. Amend § 803.52 by revising
paragraphs (b)(4), (c), and (e) to read as
follows:
§ 803.52 If I am a manufacturer, what
information must I submit in my individual
adverse event reports?
*
*
*
*
*
(b) * * *
(4) Date of this report;
*
*
*
*
*
(c) Device information (Form 3500A,
Block D). You must submit the
following:
(1) Brand name;
(2) Product code, if known, and
Common Device Name;
(3) Manufacturer name, city, and
state;
(4) Model number, catalog number,
serial number, lot number, or other
identifying number, and expiration date;
(5) Operator of the device (health
professional, lay user/patient, other);
(6) Date of device implantation
(month, day, year), if applicable;
(7) Date of device explantation
(month, day, year), if applicable;
(8) Whether the device is a single-use
device that was reprocessed and reused
on a patient (Yes, No)?
(9) If the device is a single-use device
that was reprocessed and reused on a
patient (yes to paragraph (c)(8) of this
section), the name and address of the
reprocessor;
(10) Whether the device was available
for evaluation and whether the device
was returned to the manufacturer; if so,
the date it was returned to the
manufacturer; and
(11) Concomitant medical products
and therapy dates. (Do not report
products that were used to treat the
event.)
*
*
*
*
*
E:\FR\FM\21AUP1.SGM
21AUP1
Federal Register / Vol. 74, No. 161 / Friday, August 21, 2009 / Proposed Rules
(e) Reporting information for all
manufacturers (Form 3500A, Block G).
You must submit the following:
(1) Your reporting office’s contact
name and address and device
manufacturing site;
(2) The contact’s telephone number;
(3) Your report sources;
(4) Date received by you (month, day,
year);
(5) PMA/510k Number and whether
or not the product is a combination
product;
(6) Type of report being submitted
(e.g., 5–day, initial, followup); and
(7) Your report number.
*
*
*
*
*
18. Revise the introductory text of
§ 803.53 to read as follows:
§ 803.53 If I am a manufacturer, in which
circumstances must I submit a 5-day
report?
You must submit a 5-day report to us
with the information required by
§ 803.52 in accordance with the
requirements of § 803.12(a) no later than
5 work days after the day that you
become aware that:
*
*
*
*
*
19. Amend § 803.56 by revising the
introductory text and paragraphs (a) and
(c) to read as follows:
CPrice-Sewell on DSKGBLS3C1PROD with PROPOSALS
§ 803.56 If I am a manufacturer, in what
circumstances must I submit a
supplemental or followup report and what
are the requirements for such reports?
If you are a manufacturer, when you
obtain information required under this
part that you did not provide because it
was not known or was not available
when you submitted the initial report,
you must submit the supplemental
information to us within 30 calendar
days of the day that you receive this
information. You must submit the
supplemental or followup report in
accordance with the requirements of
§ 803.12(a). On a supplemental or
followup report, you must:
(a) Indicate that the report being
submitted is a supplemental or followup
report;
*
*
*
*
*
(c) Include only the new, changed, or
corrected information.
Dated: August 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–19683 Filed 8–20–09; 8:45 am]
BILLING CODE 4160–01–S
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19:11 Aug 20, 2009
Jkt 217001
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–331]
Schedules of Controlled Substances:
Placement of 5-Methoxy-N,NDimethyltryptamine Into Schedule I of
the Controlled Substances Act
AGENCY: Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Notice of Proposed Rulemaking.
SUMMARY: The Deputy Administrator of
the Drug Enforcement Administration
(DEA) is issuing this notice of proposed
rulemaking to place the substance 5methoxy-N,N-dimethyltryptamine (5MeO-DMT) and its salts into schedule I
of the Controlled Substances Act (CSA).
This proposed action is based on a
recommendation from the Acting
Assistant Secretary for Health of the
Department of Health and Human
Services (DHHS) and on an evaluation
of the relevant data by DEA. If finalized
as proposed, this action would impose
the criminal sanctions and regulatory
controls of schedule I substances under
the CSA on the manufacture,
distribution, dispensing, importation,
exportation, and possession of 5-MeODMT.
DATES: Written comments must be
postmarked, and electronic comments
must be sent, on or before September 21,
2009. Commenters should be aware that
the electronic Federal Docket
Management System will not accept
comments after midnight Eastern time
on the last day of the comment period.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–331’’ on all written and
electronic correspondence. Written
comments being sent via regular or
express mail should be sent to the Drug
Enforcement Administration, Attention:
DEA Federal Register Representative/
ODL, 8701 Morrissette Drive,
Springfield, VA 22152. Comments may
be sent to DEA by sending an electronic
message to
dea.diversion.policy@usdoj.gov.
Comments may also be sent
electronically through https://
www.regulations.gov using the
electronic comment form provided on
that site. An electronic copy of this
document is also available at the
https://www.regulations.gov Web site.
DEA will accept electronic comments
containing Microsoft Word,
WordPerfect, Adobe PDF, or Excel files
PO 00000
Frm 00034
Fmt 4702
Sfmt 4702
42217
only. DEA will not accept any file
format other than those specifically
listed here.
Please note that DEA is requesting
that electronic comments be submitted
before midnight Eastern time on the day
the comment period closes because
https://www.regulations.gov terminates
the public’s ability to submit comments
at midnight Eastern time on the day the
comment period closes. Commenters in
time zones other than Eastern time may
want to consider this so that their
electronic comments are received. All
comments sent via regular or express
mail will be considered timely if
postmarked on the day the comment
period closes.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, Ph.D., Chief,
Drug and Chemical Evaluation Section,
Office of Diversion Control, Drug
Enforcement Administration, 8701
Morrissette Drive, Springfield, Virginia
22152, Telephone: (202) 307–7183.
SUPPLEMENTARY INFORMATION:
Comments and Requests for Hearing
In accordance with the provisions of
the CSA (21 U.S.C. 811(a)), this action
is a formal rulemaking ‘‘on the record
after opportunity for a hearing.’’ Such
proceedings are conducted pursuant to
the provisions of the Administrative
Procedure Act (5 U.S.C. 556 and 557).
All persons are invited to submit their
comments or objections with regard to
this proposal. Requests for a hearing
may be submitted by interested persons
and must conform to the requirements
of 21 CFR 1308.44 and 1316.47. The
request should state, with particularity,
the issues concerning which the person
desires to be heard and the requestor’s
interest in the proceeding. Only
interested persons, defined in the
regulations as those ‘‘adversely affected
or aggrieved by any rule or proposed
rule issuable pursuant to section 201 of
the Act (21 U.S.C. 811),’’ may request a
hearing.
21 CFR 1308.42. Please note that DEA
may grant a hearing only ‘‘for the
purpose of receiving factual evidence
and expert opinion regarding the issues
involved in the issuance, amendment or
repeal of a rule issuable’’ pursuant to 21
U.S.C. 811(a). All correspondence
regarding this matter should be
submitted to the DEA using the address
information provided above.
Posting of Public Comments
Please note that all comments
received are considered part of the
public record and made available for
public inspection online at https://
www.regulations.gov and in the Drug
E:\FR\FM\21AUP1.SGM
21AUP1
Agencies
[Federal Register Volume 74, Number 161 (Friday, August 21, 2009)]
[Proposed Rules]
[Pages 42203-42217]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19683]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 803
[Docket No. FDA-2008-N-0393]
RIN 0910-AF86
Medical Device Reporting: Electronic Submission Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its postmarket medical device reporting regulation to require that
manufacturers, importers, and user facilities submit mandatory reports
of individual medical device adverse events, also known as medical
device reports (MDRs) to the agency in an electronic format that FDA
can process, review, and archive. Mandatory electronic reporting would
improve the agency's process for collecting and analyzing postmarket
medical device adverse event information. The proposed regulatory
changes would provide the agency with a more efficient data entry
process that would allow for timely access to medical device adverse
event information and identification of emerging public health issues.
Elsewhere in this issue of the Federal Register, FDA is also announcing
a draft guidance document that provides recommendations on how to
prepare and submit electronic MDRs to FDA in a manner that satisfies
the requirements
[[Page 42204]]
of this proposed regulation. The proposal also includes modifications
to the regulations specifying the content of required MDRs to better
track information already solicited on the FDA Form 3500A.
DATES: November 19, 2009. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 (the PRA) by September
21, 2009, (see the ``Paperwork Reduction Act of 1995'' section of this
document).
ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0393 and/or RIN number 0910-AF86, by any of the following methods,
except that comments on information collection issues under the
Paperwork Reduction Act of 1995 must be submitted to the Office of
Regulatory Affairs, Office of Management and Budget (OMB) (see the
``Paperwork Reduction Act of 1995'' section of this document).
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to https://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Information Collection Provisions: The information collection
provisions of this proposed rule have been submitted to OMB for review.
Interested persons are requested to fax or e-mail comments regarding
the information collection provisions by September 21, 2009, to the
Office of Information and Regulatory Affairs, OMB. To ensure that
comments on information collection are received, OMB recommends that
written comments be faxed to 202-395-7285 or e-mailed to OIRA_submission@omb.eop.gov. Please reference this proposed rule and OMB
Control Number 0910-0437 and mark your comments to the Attention of the
FDA Desk Officer.
FOR FURTHER INFORMATION CONTACT: Howard Press, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Building 66, rm. 3320, Silver Spring, MD 20993-0002, 301-796-
6087.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Introduction
A. What Are the Medical Device Reporting Requirements?
1. What Are the Current Reporting Requirements for Manufacturers
and What Is Their Status?
2. What Are the Current Reporting Requirements for Importers?
3. What Are the Current Reporting Requirements for User Facilities?
B. What Format Is Currently Used for Submitting Postmarket Medical
Device Reports?
C. Why Is FDA Proposing to Require Electronic Submissions of MDRs?
1. What Are the Options for Electronic Reporting?
2. What Is the FDA Electronic Submission Gateway (ESG)?
3. How Do I Know FDA Received My Electronic Submission and It Was
Successfully Processed?
II. Description of the Proposed Rule
A. How Would the Rule Address Submission of Reports in Electronic
Format?
1. How Would the Reporting Requirements for Manufacturers Change
With Respect to Electronic Format?
2. How Would the Reporting Requirements for Importers Change With
Respect to Electronic Format?
3. How Would the Reporting Requirements for User Facilities Change
With Respect to Electronic Format, and How Would Annual Report
Requirements be Affected?
4. How Would the Requirement to Submit Reports in Electronic Format
Affect Recordkeeping Requirements?
B. How Would I Submit MDRs in Electronic Format?
C. How Can a Medical Device Manufacturer, Importer, or User
Facility Obtain a Variance Regarding the Requirement to Submit a Report
in Electronic Format?
D. What Other Changes Are Being Proposed?
E. When Would the Rule Become Effective?
III. What Is the Legal Authority for This Rule
IV. Is There an Environmental Impact?
V. Analysis of Impacts
A. Benefits
B. Costs
1. One-Time Costs
a. Rewriting SOPs and training personnel
b. Setting up systems for submission
c. Electronic certificates
2. Annual costs
a. Maintaining electronic certificates
b. High-speed Internet access
C. Summary of Benefits and Costs
D. Alternatives Considered
E. Regulatory Flexibility Analysis
VI. Paperwork Reduction Act of 1995
A. Reporting Requirements
B. Recordkeeping Requirements
C. Total Annual Cost Burden
VII. Federalism
VIII. Request for Comments
IX. References
I. Introduction
In this proposal, we provide background information on the current
status of FDA's medical device reporting requirements, explain the
revisions we are proposing here, and describe our approach to
electronic medical device reporting.
For over 20 years, FDA has received postmarket MDRs in a paper
format. This proposed rule to require the electronic submission to FDA
of most MDRs is an important step towards improving the agency's
systems for collecting and analyzing postmarket MDRs. The proposed rule
includes reports of deaths, serious injuries, and malfunctions that
must be reported to FDA in initial 5-day, 10-day, or 30-day individual
MDRs or in supplemental reports. We believe this proposed rule would
have the following benefits:
Reduce industry's time and costs associated with
transcribing data from internal data management systems to paper and
mailing the paper reports to the agency,
[[Page 42205]]
Eliminate the agency's transcription errors, time, and
costs associated with receiving paper reports and transcribing data to
electronic format for review and analysis,
Expedite the agency's access to safety information in a
format that would support more efficient and comprehensive data
analysis and reviews, and
Enhance the agency's ability to rapidly communicate
information about suspected problems to the medical device industry,
health care providers, consumers, and other government agencies.
In addition, this proposed rule is consistent with the Government
Paperwork Elimination Act (Public Law 105-277) requirement that Federal
agencies allow individuals or entities to submit information or
transact business with the agency electronically.
A. What Are the Medical Device Reporting Requirements?
The requirements of current medical device reporting regulations
are summarized in sections I.A.1 to I.A.3 of this document. In
addition, we address changes to these regulations to be effected
outside of this proposed rule.
Current MDR regulations (part 803 (21 CFR part 803)) require
manufacturers and importers of marketed medical devices, and user
facilities, to submit postmarket reports of individual medical device
adverse events to FDA on the FDA Form 3500A.
1. What Are the Current Reporting Requirements for Manufacturers and
What Is Their Status?
The current MDR regulation requires that manufacturers of medical
devices submit a postmarket MDR of an individual adverse event no later
than 30 calendar days after becoming aware of information that a device
the manufacturer markets may have caused or contributed to a death,
serious injury, or malfunction (Sec. 803.50). This report must be
submitted on the FDA Form 3500A, (Sec. 803.20), and contain
information described in Sec. 803.52.
In addition, the regulation requires manufacturers to provide
supplemental information about such events, on an FDA Form 3500A,
within 30 calendar days of obtaining information should such
information become available after the initial MDR was filed with FDA
(Sec. 803.56). In instances where the medical device adverse event
resulted in remedial action to prevent an unreasonable risk of
substantial harm to the public health, or at the discretion of the
agency, the regulation requires the manufacturer to submit an MDR to
the agency no later than 5 working days after becoming aware of the
information (Sec. 803.53).
Title II, section 227, of the Food and Drug Administration
Amendments Act of 2007 (FDAAA) (Public Law 110-85), amended section 519
of the Federal Food, Drug, and Cosmetic Act (the act) to require that
FDA establish criteria for manufacturer reports of malfunctions for
most class I and certain class II devices that include requiring those
reports to be in summary form and made on a quarterly basis. The types
of events required to be reported are unchanged. FDA intends to address
changes necessitated by this statutory change separately from this
proposed rule, and will address requirements for submission of those
new summary malfunction reports at that time. However, some individual
malfunction reports will continue to be required even after the FDAAA-
related changes, and as explained below, the rule proposed here does
address submission of individual malfunction reports to the agency.
2. What Are the Current Reporting Requirements for Importers?
The MDR regulation requires that importers of medical devices
submit a postmarket MDR to the agency and the manufacturer no later
than 30 calendar days after becoming aware of information that
reasonably suggests that one of the importer's marketed devices may
have caused or contributed to a death or serious injury (Sec.
803.40(a)). Importers must submit reports to the manufacturer no later
than 30 calendar days after becoming aware of information that
reasonably suggests that one of the importer's marketed devices has
malfunctioned and that this device or a similar device marketed by the
importer would be likely to cause or contribute to a death or serious
injury if the malfunction were to recur (Sec. 803.40(b)). These
reports must be submitted on the FDA Form 3500A (see Sec. 803.20) and
contain the information specified in Sec. 803.42.
3. What Are the Current Reporting Requirements for User Facilities?
The MDR regulation requires that user facilities submit a
postmarket MDR of death to the agency and an MDR of death or serious
injury to the device manufacturer within 10 working days of becoming
aware of information that reasonably suggests that a device has or may
have caused or contributed to the death or a serious injury of a
patient of the facility. (Sec. 803.30(a)). The regulation requires
that user facilities submit postmarket reports of serious injury to the
agency within 10 working days if the manufacturer of the device is
unknown or cannot be identified (Sec. 803.30(a)(2)). These reports
must be submitted on the FDA Form 3500A (see Sec. 803.20(a)), and
include the information described in Sec. 803.32.
In addition, user facilities are required to submit to the agency
an annual summary of the reports they sent to manufacturers and the
FDA, using FDA Form 3419 (Sec. 803.33). The proposal to require
submission of reports to FDA in an electronic format does not apply to
user facility annual reports made under Sec. 803.33, although other
changes to Sec. 803.33 are proposed as explained in section I.B of
this document.
B. What Format Is Currently Used for Submitting Postmarket Medical
Device Reports?
Current regulations at Sec. 803.20(a) require that user
facilities, importers, and manufacturers use the FDA Form 3500A to
submit mandatory reports about FDA-regulated devices. This requirement
took effect July 31, 1996 (see 60 FR 63578, December 11, 1995; 61 FR
16043, April 11, 1996).
Certain blocks of the FDA Form 3500A are required only for user
facilities, while others are required only for manufacturers (see Sec.
803.20(a)(2)).
Subsequent to its initial adoption, FDA revised the Form 3500A and
its instructions, adding elements including the premarket approval
application (PMA) or 510(k) number for the device, and two questions
regarding reprocessed single-use devices. The agency was required to
revise the form to include the questions regarding reprocessed single-
use devices under section 303 of the Medical Device User Fee and
Modernization Act of 2002 (Public Law 107-250). The revised FDA Form
3500A is approved under the PRA, under OMB control number 0910-0291.
FDA Form 3500A has been routinely completed on paper and
transmitted to FDA by mail, requiring FDA to manually input information
from those reports into its internal electronic systems before it can
be reviewed and analyzed. This process is extremely time consuming,
costly, and susceptible to data entry errors. Because FDA regulations
at Sec. 803.14 provide for the possibility of voluntary electronic
submission of MDRs, with agency permission, several regulations in part
803 refer to submission of reports using the FDA Form 3500A ``or an
electronic equivalent approved under section 803.14.'' (See, e.g.,
Sec. Sec. 803.30, 803.40, and 803.53.) However, reporters have not
made use of section 803.14 to
[[Page 42206]]
pursue voluntary electronic submission of MDRs, and FDA's legacy
systems were not in general designed to accept submission of MDRs in
electronic format.
C. Why Is FDA Proposing to Require Electronic Submission of MDRs?
When a medical device has been cleared for marketing and enters the
market, the product is introduced to a larger patient population in
settings different from clinical trials. New information generated
during the postmarketing period offers further insight into the
benefits or risks of the product, and evaluation of this information is
important for all products to ensure their safe use. Historically, FDA
has received almost all postmarket MDRs on paper through the mail. When
data elements are provided to FDA on only paper, the information must
be entered by hand into an electronic format for review and analysis.
This process is extremely time consuming, costly, and susceptible to
data entry errors.
The electronic submission of medical device reports would lead to
more efficient reviews, enhancing our ability to rapidly disseminate
significant information to the medical device industry, health care
providers, and consumers, in support of FDA's public health mission.
Electronic submissions would also improve the speed and efficiency
of both industry and agency operations. Electronic reporting can
benefit industry by reducing the costs associated with collating,
copying, storing, retrieving, and mailing paper medical device reports
to the agency on FDA Form 3500A. In addition, the agency benefits from
the elimination of manual data entry processes and reductions in
physical storage for paper copies of the FDA Form 3500A. Based on low
rates of participation in prior pilot voluntary electronic MDR
submission programs, FDA believes that without a regulation requiring
electronic submission of MDRs a large number of medical device firms
and user facilities would resist changing their procedures for a long
period of time. This delay would hinder our achieving the benefits of
standardized formats and quicker access to MDR data.
1. What Are the Options for Electronic Reporting?
FDA's Center for Devices and Radiological Health (CDRH) has
established its MDR databases currently to support two options for
electronic submission of MDRs: One designed for low volume reporting
and one designed for high volume reporting. Both options make use of
the FDA Electronic Submission Gateway (FDA ESG), a secure electronic
portal described further in this document, for transmission of reports
to FDA. In accordance with 21 CFR 11.2(b), CDRH is now accepting on a
voluntary basis, in lieu of paper, MDRs prepared and transmitted in
accordance with these options. More information on electronic
submission of MDRs is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm127932.htm.
For low-volume medical device reporting (few or infrequent MDRs),
the current approach developed by the agency uses the CDRH eSubmitter
(CeSub) software. The CeSub software allows for the submission of one
MDR at a time. The software provides the following tools:
Save address and contact information,
Search for a Product Code,
Search to locate a patient or Device Problem Code,
Search to find manufacturer evaluation codes (method,
result, and conclusion),
Attach documents when additional information needs to be
provided,
Produce a ``missing data report'' to help ensure that all
required information is supplied before submission to FDA.
Once the MDR is completed, the file is ``packaged for submission.''
The package generates an electronic version of the FDA Form 3500A,
which can be submitted to FDA using the FDA ESG. The final CeSub-
generated report can also be saved or printed, for recordkeeping or to
provide reports to manufacturers or other entities outside of FDA. The
CeSub software and instructions for installation are free and available
at: https://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm. We may
sometimes update or change our methodology, approach or software to
improve the low-volume reporting experience.
Reporters with large volumes of MDRs may prefer the second option,
called the Health Level 7 Individual Case Safety Report (HL7 ICSR). The
HL7 ICSR was developed in conjunction with the HL7 standards
organization to support the exchange of electronic data. This option
allows for the extraction directly from the reporter's database of
information to populate an MDR, production of the appropriate data
output, and transmission of the MDRs to the FDA ESG. The HL7 ICSR
supports the batch submission of more than one individual MDR at a
time. Reporters developing applications using the HL7 ICSR standard may
also build functions for saving or printing those reports.
The draft guidance document announced elsewhere in this Federal
Register provides information on both options for electronic submission
of MDRs.
2. What Is the FDA Electronic Submission Gateway (ESG)?
The FDA ESG is the entry point for all electronic submissions to
the agency. The FDA ESG is available 24 hours a day, 7 days a week.
Information on the FDA ESG is available at https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. To use the FDA
ESG, reporters need to have a digital certificate. A digital
certificate is an attachment to an electronic message that allows the
recipient to authenticate the identity of the sender via third party
verification from an independent certificate authority. Digital
certificates are used to identify encryption and decryption codes
between message senders and recipients. Information on digital
certificates can be found at https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm113223.htm.
3. How Do I Know FDA Received My Electronic Submission and It Was
Successfully Processed?
FDA's electronic submission processing system sends the submitter
three different acknowledgments (messages) for each submission.
Acknowledgment 1 comes from the ESG and indicates your submission was
received. Acknowledgment 2 is sent by the ESG and indicates the
submission reached CDRH. CDRH sends Acknowledgment 3 and notifies you
whether your submission was successfully loaded into CDRH's adverse
event database or the submission contained errors (specified in the
acknowledgment) during validation and loading. If your submission
contained errors, the errors need to be corrected and the corrected
reports resent.
II. Description of the Proposed Rule
A. How Would the Rule Address Submission of Reports in Electronic
Format?
This rule would revise Sec. 803.12 to require that manufacturers,
importers, and user facilities submit postmarket MDRs to the agency in
an electronic format that FDA can process, review, and archive. Under
the proposal, FDA will periodically issue information on
[[Page 42207]]
file formats, preparation and organization of files, media, method of
transmission, and other relevant technological specifications for
providing reports in an electronic format that FDA can process, review,
and archive. Proposed new Sec. 803.23 would direct reporters to the
agency's Web site to find the most updated relevant information.
Reports between manufacturers, importers, and user facilities would not
be subject to the requirement of submission in electronic format, and
may be in any format the recipient can read.
The rule would make conforming changes throughout part 803 to
reflect the proposed requirement to submit reports to FDA in electronic
format. These changes include removing Sec. 803.11, which currently
addresses obtaining paper forms, and removing Sec. 803.14, which
currently provides for voluntary electronic submission of reports with
FDA consent. The proposal would amend Sec. 803.19, which already
addresses exemptions or variances from any of the requirements of part
803, to specifically address exemption or variance from the requirement
to submit reports to FDA in electronic format. Other changes include
removing references to ``electronic equivalent[s] approved under Sec.
803.14'' from Sec. Sec. 803.13, 803.30, 803.33, 803.40, and 803.53,
and updating wording in Sec. 803.20 and 803.56 to be more consistent
with the fact that reports will not be submitted on paper (and thus,
for example, would no longer have a front and back).
If this proposed rule becomes final, manufacturers, importers, and
user facilities would be required to begin submitting medical device
reports to the agency in electronic format no later than 1 year from
the date of publication of a final rule. After the effective date, the
agency would not accept MDRs submitted on paper copies of the FDA Form
3500A, or in electronic formats other than those identified as ones
that FDA can process, review, and archive in information provided in
conjunction with this rule, unless the agency had granted an exemption
or variance as provided for in Sec. 803.19.
1. How Would the Reporting Requirements for Manufacturers Change With
Respect to Electronic Format?
The rule would amend Sec. Sec. 803.50(a), 803.53, and 803.56 to
require submission of information required by Sec. Sec. 803.52,
803.53, and 803.56 in electronic format in accordance with Sec.
803.12(a).
2. How Would the Reporting Requirements for Importers Change With
Respect to Electronic Format?
The proposed rule amends Sec. 803.40(a) to require submission to
FDA of information required by Sec. 803.42 in electronic format in
accordance with Sec. 803.12(a). The proposed electronic format
requirement does not extend to importer reports submitted to device
manufacturers, which may be in any format that the recipient can read.
3. How Would the Reporting Requirements for User Facilities Change With
Respect to Electronic Format, and How Would Annual Report Requirements
be Affected?
The proposed rule amends Sec. 803.30(a) to require submission to
FDA of information required by Sec. 803.32 in electronic format in
accordance with Sec. 803.12(a). The amendment does not impose
mandatory electronic format requirements on user facility reports
submitted to device manufacturers, which may be provided in any format
the recipient can read.
The proposed rule also makes certain changes to Sec. 803.33,
addressing user facility annual reports. Under the proposed rule, user
facilities will continue to submit annual reports on the paper FDA Form
3419. Because the proposal to require submission of individual adverse
events reports in electronic format calls for amendments to Sec.
803.12 and for removal of Sec. Sec. 803.11 (indicating how to obtain
paper forms) and 803.14 (addressing voluntary electronic submissions),
FDA is proposing to amend Sec. 803.33 to specify where to obtain the
FDA Form 3419, where to submit completed reports under that section,
and to remove references to Sec. 803.14.
4. How Would the Requirement to Submit Reports in Electronic Format
Affect Recordkeeping Requirements?
Section 803.18 of the regulation addresses requirements for
establishing and maintaining MDR files or records for manufacturers,
user facilities, and importers. FDA is proposing to amend Sec.
803.18(b)(ii) to require that MDR files contain copies of all reports
submitted under part 803, whether paper or electronic. As under the
current regulations, under the proposal, regulated entities may choose
to maintain required records either in hard copy, by printing out
reports submitted in electronic format, or in electronic form. (For
information regarding FDA's current thinking and enforcement policy
with regard to requirements for maintaining electronic records, see 21
CFR part 11 and the agency guidance document, ``Guidance for Industry:
Part 11, Electronic Records; Electronic Signatures--Scope and
Application,'' available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072322.pdf5667fnl.pdf.). FDA is also proposing to add Sec.
803.18(b)(1)(iii) to require the retention of all acknowledgments FDA
sends the manufacturer, importer, or user facility when reports are
submitted in electronic format, which will indicate the timing and
success of submission.
B. How Would I Submit MDRs in Electronic Format?
As noted previously, if the proposed rule is finalized,
manufacturers, importers, and user facilities will be required to
submit most MDRs to the agency in an electronic format that FDA can
process, review, and archive. In order to best accommodate
technological changes, FDA expects to issue information on how to
prepare and submit MDRs to the agency in a way that would satisfy the
requirements of this proposed rule. The most specific and updated
information about how to create, format, and transmit reports, using
the CeSub software (designed for low volume reporting) or the HL7 ICSR
(designed for high volume reporting), is provided on the agency's Web
site, at the address provided in proposed Sec. 803.23. The agency will
make every effort to maintain backwards compatibility when implementing
changes to the systems and formats for electronic submission. When
backwards compatibility is not possible, the agency will provide public
notice with a duration commensurate with the complexity of the change.
C. How Can a Medical Device Manufacturer, Importer, or User Facility
Obtain a Variance Regarding the Requirement to Submit a Report in
Electronic Format?
Under proposed Sec. 803.19, a manufacturer, importer, or user
facility may submit a written request to FDA seeking a variance of the
Sec. 803.12 requirement to submit reports to the agency in an
electronic format that the agency can process, review, and archive.
Written requests must contain the reason(s) why the reporting entity
requires a variance and for how long the variance is needed. FDA
anticipates receiving few variance requests because of the availability
of the Internet and the commercial availability of digital certificates
as well as FDA's free CeSub Internet software. Under the proposal, if
FDA grants a variance, the
[[Page 42208]]
manufacturer, importer, or user facility would be required to submit
MDRs as specified by FDA in the letter authorizing the variance.
D. What Other Changes Are Being Proposed?
The proposed rule would also codify the following modifications:
1. FDA proposes to remove the definition of ``Five-day report'' in
Sec. 803.3, which merely referred to a report submitted under Sec.
803.53 (the only provision of the regulation in which the term
appears), using the FDA Form 3500A or ``an electronic equivalent
approved under Sec. 803.14.'' Because this definition is not
necessary, FDA proposes to remove it.
2. FDA proposes to amend Sec. Sec. 803.32, 803.42, and 803.52 to
make minor wording changes and corrections to these sections to reflect
modifications already made to FDA Form 3500A and its instructions, with
OMB approval under the PRA. For example, section 303 of the Medical
Device User Fee and Modernization Act of 2002 (Public Law 107-250)
required FDA to modify the forms to facilitate reporting of MDRs
involving single-use devices that have been reprocessed for reuse (see
69 FR 7491, February 17, 2004). FDA is proposing to amend Sec. Sec.
803.32, 803.42, and 803.52 to reflect the addition to the FDA Form
3500A of these two questions concerning whether the device is a single
use device that has been reprocessed and reused on a patient and the
name and address of the reprocessor.
FDA is also proposing to change Sec. Sec. 803.32(b)(4),
803.42(b)(4), and 803.52(b)(4) from ``date of report by the initial
reporter'' to ``date of this report.'' This change would make part 803
consistent with the way that other FDA Centers interpret FDA Form
3500A, Block B4 and how Block B4 appears on FDA Form 3500A. Finally,
FDA is also proposing to make other minor updates to Sec. Sec.
803.32(c), 803.42(c), and 803.52(c) and (e) to reflect the changes
already made to the forms and instructions, including a reference to
the product code and PMA/510(k) number.
E. When Would the Rule Become Effective?
FDA proposes that any final rule that issues based on this proposal
become effective 1 year after the date the final rule publishes in the
Federal Register.
III. What Is the Legal Authority for This Rule?
FDA's legal authority to amend its regulations governing the
submission of postmarket medical device adverse event reports for
medical devices derives from 21 U.S.C. 352, 360, 360i, 360j, 371, and
374.
IV. Is There an Environmental Impact?
The agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
V. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). This proposed rule has
been determined to be a significant regulatory action.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because we lack information on the electronic
submission capabilities of all the firms potentially affected by this
proposed rule we have not proposed to certify that the proposed rule
would not have a significant economic impact on a substantial number of
small entities. We request commenters to submit such information in
their comments.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $133 million, using the most current (2008) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that will meet or
exceed this amount.
The purpose of this proposed rule is to require the submission of
MDRs in an electronic format the agency can process, review, and
archive. It would affect all persons subject to medical device
reporting under part 803, which includes medical device manufacturers,
device importers, and user facilities.
The proposed rule is part of a greater agency initiative to adopt
electronic technologies to improve the quality of our operations and
increase the efficiency of our resources. The rule would reduce FDA's
current costs associated with processing medical device reports (or
MDRs) that are received on the paper FDA Form 3500A. By receiving MDRs
electronically, FDA would be able to access the adverse event
information more quickly and also eliminate potential data entry errors
that could occur during input transcription of the information from the
paper FDA Form 3500A reports into our electronic medical device adverse
event reporting database.
After considering various alternatives, FDA determined that without
this regulation, the agency will need to maintain adequate resources to
continue to convert paper 3500A MDRs to electronic MDR records until
all manufacturers, importers, and user facilities voluntarily adopted
the proposed electronic submission format, possibly years in the
future.
A. Benefits
The major benefit of this proposed rule would be to public health
because the agency would have quicker access to the medical device
adverse event reports information and thus could more quickly identify
and act on any medical device problems. Currently, FDA receives 100,000
initial MDRs annually on the paper FDA Form 3500A, which are manually
entered into the FDA database. FDA receives an additional 110,000
supplemental reports each year that are also submitted on the paper FDA
Form 3500A and need to be processed and entered into the FDA database.
It can take from 3 days to more than 6 months before an MDR submitted
on a paper copy of the FDA Form 3500A may be available for analysis in
the Manufacturer and User Device Experience database (MAUDE). With a
standardized electronic format, medical device reports would become
available for analysis as soon as they are processed into MAUDE. With a
reduction in the time to manually enter the MDRs into the MAUDE
database, analysis and action, including feedback to manufacturers and
consumers, could be taken sooner with a corresponding benefit to public
health.
The public health benefits would be supplemented with operating
cost reductions within FDA. Assuming the number of MDRs remains fairly
constant over time, electronic reporting would
[[Page 42209]]
save the agency about $1.25 million annually in data entry costs, which
is about one-half of our current data entry contract.
B. Costs
There are about 18,000 medical device manufacturers and importers
identified in FDA's medical device registration database and
approximately 38,500 user facilities identified in the 2002 U.S.
Economic Census that would be affected by the proposed rule (for a
total of 56,500 manufacturers, importers, and user facilities) (Census,
2002). Table 1 shows the estimated numbers of firms and establishments
in the affected industries.
Table 1.--Affected Firms and Establishments
----------------------------------------------------------------------------------------------------------------
North American Industry No. of
Classification System (NAICS) Code Description No. of Firms Establishments
----------------------------------------------------------------------------------------------------------------
Various Devices 18,000 8,000
----------------------------------------------------------------------------------------------------------------
622 Hospitals 3,800 6,342
----------------------------------------------------------------------------------------------------------------
6231 Nursing care facilities 7,826 15,480
----------------------------------------------------------------------------------------------------------------
6214 Outpatient care centers 11,125 23,912
----------------------------------------------------------------------------------------------------------------
6215 Medical and diagnostic 5,736 9,844
laboratories
----------------------------------------------------------------------------------------------------------------
6216 Home health care services 9,987 15,016
----------------------------------------------------------------------------------------------------------------
Total 56,474 88,594
----------------------------------------------------------------------------------------------------------------
The incremental cost of changing to electronic submissions for each
affected entity would vary by the size, type, and corporate structure
of the firm, as well as by its current electronic submission
capability. The total costs associated with this proposed rule would
include one-time set-up costs and annual operating costs.
1. One-Time Costs
One-time costs would be the sum of the costs of:
Rewriting standard operating procedures (SOPs) and
training the appropriate personnel,
Installing and validating either the installation of
CDRH's CeSub Web interface software or the programming and
configuration of a computer system to transmit reports directly to the
FDA ESG using the HL7 ICSR, and
Acquiring the electronic digital certificate required by
the FDA ESG.
a. Rewriting SOPs and training personnel. All entities affected
would need to update their SOPs to include the electronic submission
requirement. For medical device manufacturers, importers, and
hospitals, we estimate that it would require about 10 hours to make the
modifications and train the appropriate people on the new procedures.
For the other user facilities, we assume that the corporate or regional
offices would have the major responsibility for medical device
reporting and thus the SOPs for these individual entities would require
less time to modify. For this analysis we estimated that 55 percent of
the other user facilities would require about 10 hours to modify their
SOPs and the remaining 45 percent would require about 2 hours.\1\ The
estimated one-time incremental cost for updating SOPs, assuming an
average wage rate of $52 per hour,\2\ (Bureau of Labor Statistics
(BLS), 2006) is about $34.1 million [((18,000 medical device
manufacturers and importers + 6,300 hospitals) x 10 hours) + ((0.45 x 2
hours + 0.55 x 10 hours) x 64,500 other user facilities) x $52/hour].
---------------------------------------------------------------------------
\1\ Percentages are based on the ratio of firms to
establishments from 2002 Census of Manufactures data.
\2\ $52 per hour wage is based on BLS Occupational Employment
and Wages, May 2006, for Medical and Health Service Managers,
Standard Occupational Classification 11-19111. Forty percent was
added to the mean hourly wage of $37.09 to account for benefits and
the total was rounded to the nearest whole number.
---------------------------------------------------------------------------
b. Setting up systems for submission. MDRs would be submitted
through the FDA ESG using one of two methods: The CDRH CeSub software
or the HL7 ICSR. Because most entities are small and submit few if any
MDRs annually, we assume they would probably use the CDRH CeSub
software, which allows for the submission of one MDR at a time. To
comply using this submission method, manufacturers, importers, and user
facilities would need high-speed Internet connections and would have to
download and install up to three free software programs, validate the
installation, and train the appropriate personnel on the new
procedures. Entities that have dedicated information technology (IT)
staff would be able to install and validate the installation
themselves. Smaller manufacturers, importers, and user entities would
probably choose to hire an outside contractor for the installation and
its validation.
We do not have data on the amount of time required to install and
validate the installation of the software or the percentage of entities
that might need to contract out the installation. For this analysis, we
assumed it would take an entity 8 to 16 hours to install and validate
the installation of CDRH's CeSub software and install, if necessary,
Java Runtime Edition software and Java security policy files for their
Internet browser. This estimate also includes the time required to
notify FDA, run a test submission through the FDA ESG, and to train the
appropriate staff to use the new program. We are also assuming that
almost all medical device manufacturers, importers, and all user
facilities would use this method to submit MDRs. Using an average wage
of $46.50 for computer and mathematical occupations\3\ (BLS 2006), we
estimate the cost to install and use the software to be between $21.0
million and $41.7 million [(8 hours x $46.50 wage) x (38,500 user
facilities + 18,000 manufacturers and importers) to (16 hours x $46.50
wage) x (38,500 user facilities + 18,000 manufacturers and importers)].
---------------------------------------------------------------------------
\3\ BLS Occupation Employment and Wages, May 2006, by
occupation, for all industries (https://www.bls.gov). Wage ($46.50)
includes mean hourly wage of $33.22 for Standard Occupational
Classification 15-0000, computer and mathematics occupations, all
industries; we add 40 percent to account for benefits.
---------------------------------------------------------------------------
Entities that submit a large number of MDRs each year may choose to
use the HL7 ICSR method to submit the reports.
[[Page 42210]]
This method allows for the batch submission of multiple MDRs at faster
transmission rates. We do not know at what threshold of reporting it
becomes cost effective for an entity to submit medical device reports
using this method. An analysis of FDA submission data for a 6-year
period indicated that about 20 large medical device manufacturers
submit 500 or more MDRs each year and about 85 submit close to 100
medical device reports per year. We assumed that the actual number of
entities using the HL7 ICSR would fall somewhere within this range (20
to 85). We also assumed that only entities that have existing
infrastructure to support HL7 ICSR transmissions would choose this
method to submit MDRs. We estimated that it would take about 50 hours
to set up their gateway to be compatible with the agency's system.
Using the wage $46.50, the one-time cost for establishing HL7 ICSR
submission capabilities would range between $50 thousand and $200
thousand [($46.50 x 50 hours) x 20 entities) and ($46.50 x 50 hours) x
85 entities)].
c. Electronic certificates. All entities would need an electronic
certificate to submit any electronic regulatory document to the FDA
ESG. The electronic certificate identifies the sender and serves as an
electronic signature. Entities that have not submitted any electronic
documents to the agency would incur a one-time cost to acquire the
certificate and recurring costs to keep the certificate active as a
result of this proposed rule. The certificates cost about $20 and are
valid for 1 year. We assume that the search and transactions costs
involved in the initial acquisition of the certificate doubles the cost
of the certificate to a total of $40 for the first year, half of which
would be setup costs. If all entities needed to acquire electronic
certificates, the one-time search and acquisition costs would be $1.1
million ($20 acquisition cost x 56,500 entities).
In addition to the costs we have estimated, manufacturers,
importers, and user facilities affected by this proposed rule may have
to hire outside expertise to install and validate the software
installation to comply with the proposed requirements.
Table 2 summarizes the estimated one-time costs by type of cost for
this proposed rule by cost and type of manufacturers, importers, and
user entities. The estimate of the total one-time costs for all
manufacturers, importers, and user facilities ranges from $58.6 million
to $79.7 million. Much of the cost involves acquiring the electronic
certificate for the capability to submit any regulatory document to the
FDA, including installation and validation of the CeSub software or to
establish HL7 ICSR capabilities. Therefore, manufacturers, importers,
and user facilities that are not already making electronic submissions
of any kind to the agency if this proposed rule becomes final would
incur these total costs.
Table 2.--Summary of One-Time Costs by Industry ($ Million)
----------------------------------------------------------------------------------------------------------------
Install and validate Gateway to gateway Total
Modifying CeSub software -------------------------- Acquiring e--------------------------
Industry SOPs -------------------------- certificate
low high low high low high
----------------------------------------------------------------------------------------------------------------
Medical 9.4 6.7 13.4 0.05 0.2 0.4 16.6 23.4
Device
----------------------------------------------------------------------------------------------------------------
User 26.9 14.3 28.6 ........... ........... 0.8 42.0 56.3
Facilit
y
----------------------------------------------------------------------------------------------------------------
Total 36.3 21.0 42.0 0.05 0.2 1.2 58.6 79.7
----------------------------------------------------------------------------------------------------------------
Annualized at 3 percent over 10 years 6.9 9.3
----------------------------------------------------------------------------------------------------------------
Annualized at 7 percent over 10 years 8.3 11.4
----------------------------------------------------------------------------------------------------------------
2. Annual Costs
The annual costs of this proposed rule would include the costs of:
Maintaining certificates and
High-speed Internet access.
a. Maintaining electronic certificates. Manufacturers, importers,
and user facilities would bear the cost to maintain the electronic
certificate that identifies the sender. In addition to having to renew
the certificate on a regular basis, those entities who have not
submitted MDRs would also have to ensure they are capable of
transmitting electronic MDRs to FDA should such a report submission be
necessary. To add these costs to the cost of the certificate itself, we
assume that entities would incur an additional annually recurring cost
equal to one-half the price of the certificate ($10), for a total
annually recurring cost of $30. If all manufacturers, importers, and
user facilities need to acquire electronic certificates, the annual
cost would be $1.7 million ($30 acquisition certificate renewal and
acquisition cost x 56,500 entities).
b. High-speed Internet access. Entities would also need high-speed
Internet access to use either of the submission methods. A 2004 study
of small businesses sponsored by the Small Business Administration
(SBA) found that essentially all small firms had Internet access and
about 50 percent had high-speed Internet access (Pociask, 2004). The
average cost of high speed access was about $40 per month more than
dial-up access. Because the average cost of Internet access has been
going down over time, we estimate that by the time this proposed rule
would be made final, about 75 percent of device and user facilities
would have high speed access. The average annual recurring increase in
cost for high speed Internet access for the remaining 25 percent of the
entities would be $6.8 million (($40 x 12 months) x (0.25 x (18,000
manufacturers and importers + 38,500 user facilities))).
Table 3 shows the annual costs of the proposed rule. As with the
one-time costs, only entities not making electronic regulatory document
submissions of any kind to the agency if this proposed rule becomes
final would incur all these costs. There would be no change in the
actual time required to research and prepare the MDRs, nor would there
be any additional reporting requirements as a result of this proposed
rule. Manufacturers, importers, and user facilities that maintain paper
FDA Form 3500A records for their internal MDR files own use could still
do so under the proposed rule.
[[Page 42211]]
Table 3.--Summary of Annual Costs by Industry ($ million)
----------------------------------------------------------------------------------------------------------------
Acquiring
Industry electronic High-speed Internet Total
certificate access
----------------------------------------------------------------------------------------------------------------
Medical Device 0.5 2.2 ...................
----------------------------------------------------------------------------------------------------------------
User Facility 1.2 4.6 ...................
----------------------------------------------------------------------------------------------------------------
Total 1.7 6.8 8.5
----------------------------------------------------------------------------------------------------------------
Cost savings: We estimate a modest industry savings of about $3.2
million annually because electronic submission should reduce the time
it takes to submit documents. It should be noted that the savings
accumulate to firms submitting MDRs; firms that submit very few or no
MDRs would not realize any savings.
C. Summary of Benefits and Costs
The principal benefit of this proposed rule would be the public
health benefits associated with more rapid processing and analysis of
the 100,000 initial individual MDRs currently submitted to FDA on a
paper FDA Form 3500A. In addition, requiring electronic submission of
MDRs is expected to reduce FDA annual operating costs by $1.25 million
and generate industry savings of about $3.2 million.
The total one-time cost for modifying SOPs and establishing
electronic submission capabilities is estimated to range from $58.6
million to $79.7 million. Annually recurring costs totaled $8.5 million
and include maintenance of electronic submission capabilities,
including renewing the electronic certificate, and for some entities
the incremental cost to maintain high-speed Internet access. The total
annualized cost of the proposed rule, assuming a 7-percent discount
rate over 10 years, would be from $16.8 million to $19.9 million ($15.4
million to $17.8 million at a 3-percent discount rate). We request
comment on the accuracy and completeness of the assumptions used to
estimate the costs of this proposed rule. For example, we invite
comment on our use of a 10-year time horizon and whether a shorter or a
longer horizon would be more appropriate to express the social costs of
this proposed rule.
D. Alternatives Considered
During the development of this proposed rule, we considered a
number of alternative approaches. The first was to allow manufacturers,
importers, and user facilities to voluntarily submit MDRs
electronically. Because our experience has shown that a number of
medical device firms and user facilities would resist changing their
procedures for a long period of time, we would not attain the benefits
of standardized formats and quicker access to medical device adverse
event data. The FDA, for example, would have to maintain contracts to
handle the input of information from both written and electronic MDRs.
A voluntary system, therefore, would fail to achieve the goals of this
proposed rule.
Another alternative was to allow small entities more time to comply
with the electronic submission requirements. This alternative would
allow small entities to delay compliance. Under this alternative, we
would not receive the full data-entry savings from requiring electronic
submissions or all the benefits of quicker access to these reports.
Because so many device companies are small entities, this approach
would significantly postpone the benefits the rule is intended to
confer. Moreover, as shown in the following section, the estimated
incremental costs per small entity from the proposed rule are small, so
the cost reduction per small entity from delayed compliance would also
be small.
E. Regulatory Flexibility Analysis
The SBA defines a small medical device manufacturer as having fewer
than 500 employees. Based on data from U.S. Census, about 98 percent of
device firms affected by this proposed rule are considered small
entities, and have an average value of shipments of about $9.0
million.\4\ Businesses in the health care industry are classified as
small if their revenues are below a certain level. Hospitals are small
if their total revenue falls below $25 million and the other user
facilities are considered small if their revenues are below $10
million. U.S. Census data indicates that about 87 percent of the user
facilities are classified as small and have a weighted average revenue
of about $3.3 million.\5\ However, very few user facilities submit MDRs
in any given year. While this proposed rule will now require those
reports submitted to the agency to be in electronic format, the content
of a report is not being changed from that already addressed on the
current FDA Form 3500A. The average costs for these manufacturers,
importers, and user facilities are listed in table 4. The average total
annualized cost per small entity, assuming a 7-percent discount rate
over 10 years, would range from $581 to $693; at a 3-percent discount
rate, average annualized costs would range from $568 to $661. These
costs represent less than 0.1 percent of revenues for medical device
firms and less than 0.1 percent of revenues for user facilities.
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\4\ U.S. Census Bureau, 2002 Economic Census, Manufacturing
Industry Series, Industry Statistics by Employment Size for NAICS
codes: 334510, 339112, 339113, 339114, and 339115 (www.census.gov).
\5\ U.S. Census Bureau, 2002 Economic Census, Release Date 11/
22/2005, Sector 62: Health Care and Social Assistance: Subject
Series--Establishment and Firm Size: Receipts/Revenue Size the
United States for NAICS 622, 6231, 6214, 6215, and 6216 accessed via
American Fact Finder (www.census.gov).
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We considered two possible alternatives for regulatory relief for
small businesses. As described above, one regulatory alternative would
be longer compliance times for small entities. We would not receive the
full data-entry savings from requiring electronic submissions or all
the benefits of quicker access to these reports. Because so many device
companies are small entities, this approach would significantly
postpone the benefits the rule is intended to confer. Moreover, as
shown above, the estimated incremental costs per small entity from the
proposed rule are small, so the cost reduction per small entity from
delayed compliance would also be small.
In addition, we considered proposing a waiver to the electronic
submission requirement for small firms that can demonstrate an economic
hardship. Because the estimated incremental costs per small entity from
the proposed rule are small, the cost reduction per small entity from a
waiver would also be small.
We ask for comments on both of these options for regulatory relief
for small entities.
While the estimated costs per affected entity are low, FDA does not
have adequate information on the electronic capabilities of all of the
firms affected
[[Page 42212]]
by this proposed rule and has made many assumptions to derive these
estimate used in this analysis, therefore we do not propose to certify
that this proposed rule would not have a significant economic impact on
a substantial number of small entities. FDA requests comment on this
issue.
Table 4.--Incremental Compliance Costs per Small Entity
----------------------------------------------------------------------------------------------------------------
One-Time Costs Total Annualized
-------------------------------- Annually -------------------------------
low high Recurring low high
----------------------------------------------------------------------------------------------------------------
Rewriting SOPs 104 520 .............. .............. ..............
----------------------------------------------------------------------------------------------------------------
Software Installation and 372 744 ..............
validation of installation
----------------------------------------------------------------------------------------------------------------
Acquiring Electronic Certificate 40 ..............
----------------------------------------------------------------------------------------------------------------
Maintaining submission 30
capabilities
----------------------------------------------------------------------------------------------------------------
Upgrade Internet Access 480 .............. ..............
----------------------------------------------------------------------------------------------------------------
7 percent discount rate .............. 581 693
----------------------------------------------------------------------------------------------------------------
3 percent discount rate .............. 568 661
----------------------------------------------------------------------------------------------------------------
VI. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by OMB under the PRA (44 U.S.C. 3501-3520). A
description of these provisions is given in this document with an
estimate of the annual reporting and recordkeeping burden. Included in
the estimate is the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing each collection of information.
FDA invites comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Medical Device Reporting
Description: In accordance with the proposed Medical Device
Reporting regulation, medical device manufacturers, importers, and user
facilities would be required to submit MDRs to FDA, to maintain
records, and may also seek exemption or variance from these
requirements. FDA is also proposing to amend Sec. Sec. 803.32, 803.42,
and 803.52 to make minor wording changes and corrections to these
sections to reflect modifications already made to FDA Form 350