Pilot Program for Center for Devices and Radiological Health Electronic Submission of Premarket Notification Submissions, 24732-24734 [2014-09912]
Download as PDF
<![CDATA[
24732
Federal Register / Vol. 79, No. 84 / Thursday, May 1, 2014 / Notices
cure and (2) the number of affected
pediatric patients.
The purpose of this guidance
document is to describe the type of
information that FDA believes is
readily-available to the applicant, and
the information FDA believes should be
included in a submission to meet the
requirements of section 515A(a) of the
FD&C Act. The draft version of this
guidance was issued on February 19,
2013 (78 FR 11654).
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on the requirements
relating to the submission of
information on pediatric subpopulations
that suffer from the disease or condition
that a device is intended to treat,
diagnose, or cure. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statute
and regulations.
tkelley on DSK3SPTVN1PROD with NOTICES
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov or from
CBER at https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/default.htm.
Persons unable to download an
electronic copy of ‘‘Providing
Information about Pediatric Uses of
Medical Devices,’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 1801 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
On January 9, 2014, the Agency
submitted a proposed collection of
information entitled ‘‘Providing
Information About Pediatric Uses of
Medical Devices Under Section 515A of
the Federal Food, Drug and Cosmetic
Act’’ to OMB for review and clearance
under 44 U.S.C. 3507. An Agency may
not conduct or sponsor, and a person is
not required to respond to, a collection
of information unless it displays a
currently valid OMB control number.
VerDate Mar<15>2010
17:30 Apr 30, 2014
Jkt 232001
OMB has now approved the information
collection and has assigned OMB
control number 0910–0762. The
approval expires on March 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
This guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in 21
CFR part 814, subpart B have been
approved under OMB control number
0910–0231 and the collections of
information in 21 CFR part 814, subpart
H have been approved under OMB
control number 0910–0332.
V. Comments
Interested persons may submit either
written comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
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, and
will be posted to the docket at https://
www.regulations.gov.
Dated: April 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–09897 Filed 4–30–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0366]
Pilot Program for Center for Devices
and Radiological Health Electronic
Submission of Premarket Notification
Submissions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) Center for
Devices and Radiological Health (CDRH)
is announcing the availability of a
CDRH eSubmissions Pilot Program
(eSubmissions Pilot), which will be a
new pathway that will guide the user
through constructing and submitting
their 510(k) submissions electronically
without the requirement for submitting
a hard copy or a compact disc.
Participation in the eSubmissions Pilot
is open to applicants whose device
SUMMARY:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
submissions would be reviewed in
either of two branches in CDRH’s Office
of Device Evaluation (ODE), the Cardiac
Diagnostic Devices Branch and the
Peripheral Interventional Devices
Branch, and is limited to unbundled,
traditional 510(k) submissions for
classified devices only. The
eSubmissions Pilot will use the existing
eSubmitter software for data acquisition
and the existing Electronic Submission
Gateway (ESG) for submitting (the
eSubmissions Pilot is not intended to
evaluate the existing eSubmitter
software or the existing ESG). The
eSubmissions Pilot is intended to
provide industry and CDRH staff the
opportunity to evaluate the 510(k)
eSubmission with regards to the content
(wording of questions, help text and
guides), layout, and flow of the
questions.
DATES: FDA will begin accepting
requests to participate in the
eSubmissions Pilot immediately. See
the ‘‘Procedures’’ section for
instructions on how to submit a request.
FOR FURTHER INFORMATION CONTACT:
Patrick Axtell, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1566, Silver Spring,
MD 20993–0002, eSubpilot@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has been moving toward
transforming all regulatory submissions
from paper to electronic methods. Since
January 1999, FDA has accepted
voluntary electronic submissions for
certain types of regulatory submissions.
FDA presently utilizes eSubmitter as a
platform for submitting many types of
submissions across several Centers. The
eSubmitter platform contains templates
for many types of submissions specific
to those Centers and any template can
be chosen by the user for constructing
and submitting the appropriate type of
submission. The 510(k) eSubmission
program introduces a new template in
eSubmitter for use in submitting 510(k)s
to ODE.
FDA presently utilizes the ESG for the
receipt and processing of many types of
electronic regulatory submissions
(https://www.fda.gov/ForIndustry/
ElectronicSubmissionsGateway/
default.htm). The ESG automates the
receipt, acknowledgment, routing and
notification of electronic submissions
via the Internet and meets FDAs
standards of electronic information
exchange.
The benefits to industry of this pilot
program include, but are not limited to:
E:\FR\FM\01MYN1.SGM
01MYN1
Federal Register / Vol. 79, No. 84 / Thursday, May 1, 2014 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
• Application of the ‘‘Refuse to
Accept Policy for 510(k)s’’ (RTA)
guidance document will be waived
during the pilot (i.e., no submissions
submitted via the software will be
subject to an acceptance review as
outlined in the RTA guidance).
• A guided interface that leads the
sponsor through the process of
constructing and submitting their 510(k)
submissions. Built into the software are
a number of features that ensure
appropriate regulatory submission
standards and recommendations are met
or considered. Further, software features
will prompt the inclusion of
information that will avert some of the
common procedural and administrative
issues reviewers find during their
reviews.
• The 510(k) eSubmissions are
expected to decrease both the time spent
by industry creating and submitting the
510(k).
• The 510(k) eSubmission process
may also reduce the number of
questions asked by FDA to which the
applicant must officially respond.
• Since the 510(k) submission process
will be completely electronic, time will
not be lost in physical transit of the
submission to FDA.
• The eSubmission software is
intended to be a guide for users to
instruct them as to what is required and
recommended when submitting a
510(k), and will act as an aid for
learning about the process. The use of
electronic signatures will allow
sponsors to legally sign documents
without the need for printing, scanning
and uploading.
The benefits to FDA include, but are
not limited to:
• A reduction in required resources
and time spent in processing the
submission for review.
• Easier and faster reviews due to a
standardized submission structure.
510(k) eSubmissions also support the
Secretary’s health IT priorities to
harness information technology to
improve health care and patient safety.
The information learned and
experiences gained from the
eSubmissions Pilot will be used to
optimize the process by which data and
documents are obtained and ensure that
the software infrastructure functions
properly and electronic signatures work
as intended.
II. CDRH eSubmissions Pilot
The eSubmissions Pilot presents a
voluntary process to interested
sponsors. This notice outlines: (1) The
guiding principles underlying the
eSubmissions Pilot; (2) the scope of the
eSubmissions Pilot; and (3) the
VerDate Mar<15>2010
17:30 Apr 30, 2014
Jkt 232001
procedures CDRH intends to follow for
the eSubmissions Pilot. The
eSubmission process works similarly to
commercially available tax preparation
software packages such that it guides
the sponsor through the submission
process. Help text, links, embedded
guides, and other aids are intended to
assist the user and allow novice 510(k)
submitters to navigate through the
process of submitting a 510(k)
submission. The software will consist of
textual suggestions and questions
designed to obtain all of the data FDA
needs to review the submission and
ensure no required data are omitted.
FDA intends to collect data via text
fields, checkboxes, dropdown menus,
and, where it would be burdensome to
collect data via these methods, file
attachments. For example, FDA intends
to collect much of the administrative
data as well as basic information, such
as the Indications for Use, via the
software interface, not via file
attachments. However, instruction
manuals, software documentation,
performance testing and other large
documents may be attached.
A. Guiding Principles
The following basic principles
underline the eSubmissions Pilot
described in this document. CDRH
intends that these principles create a
common understanding between the
sponsor and CDRH about the goals and
parameters of the eSubmissions Pilot:
1. FDA believes the use of the
eSubmission process will result in
administratively complete 510(k)
submissions and will not be conducting
a separate acceptance review for the
files submitted through the
eSubmissions Pilot.
2. The eSubmission will serve as the
only submission required; no other
copies of the submission will be
required.
3. The submission of Amendments
and Supplements needs to be completed
through the software during the
eSubmissions Pilot. FDA encourages
sponsor and reviewer interaction during
the review process.
4. FDA will not publicly disclose
participation of a sponsor in the
eSubmissions Pilot, unless the sponsor
consents or has already made this
information public, or disclosure is
required by law.
5. Participating in this eSubmissions
Pilot does not guarantee clearance of a
sponsor’s 510(k) submission, nor is a
sponsor precluded from withdrawing
from the eSubmissions Pilot and
pursuing a conventional 510(k)s
submission and review through the
current pathway.
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
24733
6. Due to FDA resource issues, FDA
intends to limit the eSubmissions Pilot
to approximately 50 to 100 submissions.
FDA may further limit the number of
submissions from an individual firm as
resources and eSubmissions Pilot needs
allow.
7. An Extensible Markup Language
(XML) Schema Definition (XSD) for the
eSubmissions Pilot template was
produced, and FDA intends to allow
future submissions using alternative
approaches to eSubmitter (e.g., via
proprietary software purchased or
produced by a medical device firm), as
long as the submission is compliant
with the XSD. If FDA commits to also
receiving Regulated Product
Submissions (RPS) in the future, FDA
intends to expand this method of receipt
to accept RPS packages. In addition, a
different, more modern platform may be
used for future eSubmissions other than
eSubmitter.
B. Scope of eSubmissions Pilot
Voluntary participation in the
eSubmissions Pilot is open to sponsors
whose submissions are reviewed in
ODE’s Division of Cardiovascular
Devices Cardiac Diagnostic Devices
Branch or Peripheral Interventional
Devices Branch. We encourage 510(k)
sponsors of all device types, including
those reviewed in other branches, to
review the software interface and
provide feedback via https://
www.regulations.gov or the Division of
Dockets Management (see Comments).
The eSubmissions Pilot is limited to
unbundled, traditional 510(k)
submissions for classified devices only.1
C. Procedures
The following procedures have been
developed to manage the CDRH
eSubmissions Pilot effectively:
1. Under the eSubmissions Pilot,
510(k) submissions will be reviewed
according to CDRH standard
procedures.
2. eSubmission will be available for
use and submission 24 hours a day and
7 days a week. However, if a 510(k) is
received outside of normal business
hours (Monday to Friday, 8 a.m. to 4:30
p.m. excluding Federal holidays or
dates the Federal Government is
shutdown), the submission receipt date
will be considered the next business
day.
3. Participation in the eSubmissions
Pilot does not affect submission user fee
obligations. If the required user fee is
not paid at the time of submission, the
1 We are not accepting third party 510(k)s or
Combination Products in the eSubmissions Pilot at
this time.
E:\FR\FM\01MYN1.SGM
01MYN1
24734
Federal Register / Vol. 79, No. 84 / Thursday, May 1, 2014 / Notices
receipt date will be the receipt date of
a complete User Fee Coversheet via
eSubmission. If a User Fee Coversheet is
submitted outside of normal business
hours (Monday to Friday, 8 a.m. to 4:30
p.m. excluding Federal holidays or
dates the Federal Government is
shutdown), the User Fee Coversheet
receipt date will be considered the next
business day.
4. Volunteers interested in
participating in the CDRH 510(k)
eSubmissions Pilot should contact
eSubmissions Pilot staff by email at
eSubpilot@fda.hhs.gov. This email
address should also be used to report
issues and ask questions. General
feedback and comments about the
eSubmissions Pilot, 510(k) template,
and process can be provided via
https://www.regulations.gov or the
Division of Dockets Management (see
Comments).
5. Additional information on the
CDRH 510(k) eSubmissions Pilot is
available at https://www.fda.gov/
ForIndustry/FDAeSubmitter/
ucm221506.htm.
III. Duration of the eSubmissions Pilot
FDA intends to accept requests for
participation in the eSubmissions Pilot
through September 30, 2014, or as
resources and eSubmissions Pilot needs
allow. Modifications to the CDRH 510(k)
eSubmissions Pilot will be made
available at https://www.fda.gov/
ForIndustry/FDAeSubmitter/
ucm221506.htm to all eSubmissions
Pilot participants and stakeholders.
eSubmissions Pilot for CDRH Electronic
Submission of Premarket Notification
Submissions to https://
www.regulations.gov or written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
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, and
will be posted to the docket at https://
www.regulations.gov.
Dated: April 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–09912 Filed 4–30–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2011–N–0021]
Actavis Totowa LLC, et al.; Withdrawal
of Approval of Abbreviated New Drug
Applications for Prescription Pain
Medications Containing More Than 325
Milligrams of Acetaminophen;
Correction
Rachel Turow, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6236,
Silver Spring, MD 20993–0002, 301–
796–5094.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
IV. Comments
Interested persons may submit
electronic comments regarding the
notice that appeared in the Federal
Register of March 27, 2014 (79 FR
17163). The document withdrew
approval of 108 abbreviated new drug
applications (ANDAs) for prescription
pain medications containing more than
325 milligrams (mg) of acetaminophen
per dosage unit from multiple
applicants, effective March 27, 2014.
The document failed to withdraw
approval of ANDAs 040825, 040822,
and 040824, held by Ranbaxy
Laboratories Inc. and Ranbaxy Inc., 600
College Rd. East, Princeton, NJ 08540,
and ANDA 040182, held by
Pharmaceutical Associates, Inc., 201
Delaware St., Greenville, SC 29605. The
holders of these applications have
voluntarily requested that approval of
these applications be withdrawn and
have waived their opportunity for a
hearing. FDA confirms the withdrawal
of approval of ANDAs 040825, 040824,
040822, and 040182.
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
SUMMARY:
In FR Doc.
2014–06801, appearing on page 17163,
in the Federal Register of Thursday,
March 27, 2014, the following
correction is made:
On page 17166, in table 1, the
following entries are added in
alphabetical order by Applicant:
Application
No.
Drug product(s)
Applicant or holder
ANDA 040182
Acetaminophen and Hydrocodone Bitartrate Oral Solution, 7.5
mg/500 mg/15 milliters (mL), available in 473 mL, 118 mL,
15 mL, and 10 mL.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5
mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/
7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/
10 mg.
Pharmaceutical Associates, Inc., 201 Delaware St., Greenville,
SC 29605.
ANDA 040825
ANDA 040822
ANDA 040824
Ranbaxy Laboratories Inc., 600 College Rd. East, Princeton,
NJ 08540.
Do.
Ranbaxy Inc., 600 College Rd. East, Princeton, NJ 08540.
tkelley on DSK3SPTVN1PROD with NOTICES
Dated: April 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–09898 Filed 4–30–14; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
17:30 Apr 30, 2014
Jkt 232001
PO 00000
Frm 00068
Fmt 4703
Sfmt 9990
E:\FR\FM\01MYN1.SGM
01MYN1
]]>Agencies
[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Notices]
[Pages 24732-24734]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09912]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0366]
Pilot Program for Center for Devices and Radiological Health
Electronic Submission of Premarket Notification Submissions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) Center for Devices and
Radiological Health (CDRH) is announcing the availability of a CDRH
eSubmissions Pilot Program (eSubmissions Pilot), which will be a new
pathway that will guide the user through constructing and submitting
their 510(k) submissions electronically without the requirement for
submitting a hard copy or a compact disc. Participation in the
eSubmissions Pilot is open to applicants whose device submissions would
be reviewed in either of two branches in CDRH's Office of Device
Evaluation (ODE), the Cardiac Diagnostic Devices Branch and the
Peripheral Interventional Devices Branch, and is limited to unbundled,
traditional 510(k) submissions for classified devices only. The
eSubmissions Pilot will use the existing eSubmitter software for data
acquisition and the existing Electronic Submission Gateway (ESG) for
submitting (the eSubmissions Pilot is not intended to evaluate the
existing eSubmitter software or the existing ESG). The eSubmissions
Pilot is intended to provide industry and CDRH staff the opportunity to
evaluate the 510(k) eSubmission with regards to the content (wording of
questions, help text and guides), layout, and flow of the questions.
DATES: FDA will begin accepting requests to participate in the
eSubmissions Pilot immediately. See the ``Procedures'' section for
instructions on how to submit a request.
FOR FURTHER INFORMATION CONTACT: Patrick Axtell, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1566, Silver Spring, MD 20993-0002,
eSubpilot@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has been moving toward transforming all regulatory submissions
from paper to electronic methods. Since January 1999, FDA has accepted
voluntary electronic submissions for certain types of regulatory
submissions. FDA presently utilizes eSubmitter as a platform for
submitting many types of submissions across several Centers. The
eSubmitter platform contains templates for many types of submissions
specific to those Centers and any template can be chosen by the user
for constructing and submitting the appropriate type of submission. The
510(k) eSubmission program introduces a new template in eSubmitter for
use in submitting 510(k)s to ODE.
FDA presently utilizes the ESG for the receipt and processing of
many types of electronic regulatory submissions (https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm). The ESG
automates the receipt, acknowledgment, routing and notification of
electronic submissions via the Internet and meets FDAs standards of
electronic information exchange.
The benefits to industry of this pilot program include, but are not
limited to:
[[Page 24733]]
Application of the ``Refuse to Accept Policy for 510(k)s''
(RTA) guidance document will be waived during the pilot (i.e., no
submissions submitted via the software will be subject to an acceptance
review as outlined in the RTA guidance).
A guided interface that leads the sponsor through the
process of constructing and submitting their 510(k) submissions. Built
into the software are a number of features that ensure appropriate
regulatory submission standards and recommendations are met or
considered. Further, software features will prompt the inclusion of
information that will avert some of the common procedural and
administrative issues reviewers find during their reviews.
The 510(k) eSubmissions are expected to decrease both the
time spent by industry creating and submitting the 510(k).
The 510(k) eSubmission process may also reduce the number
of questions asked by FDA to which the applicant must officially
respond.
Since the 510(k) submission process will be completely
electronic, time will not be lost in physical transit of the submission
to FDA.
The eSubmission software is intended to be a guide for
users to instruct them as to what is required and recommended when
submitting a 510(k), and will act as an aid for learning about the
process. The use of electronic signatures will allow sponsors to
legally sign documents without the need for printing, scanning and
uploading.
The benefits to FDA include, but are not limited to:
A reduction in required resources and time spent in
processing the submission for review.
Easier and faster reviews due to a standardized submission
structure.
510(k) eSubmissions also support the Secretary's health IT
priorities to harness information technology to improve health care and
patient safety. The information learned and experiences gained from the
eSubmissions Pilot will be used to optimize the process by which data
and documents are obtained and ensure that the software infrastructure
functions properly and electronic signatures work as intended.
II. CDRH eSubmissions Pilot
The eSubmissions Pilot presents a voluntary process to interested
sponsors. This notice outlines: (1) The guiding principles underlying
the eSubmissions Pilot; (2) the scope of the eSubmissions Pilot; and
(3) the procedures CDRH intends to follow for the eSubmissions Pilot.
The eSubmission process works similarly to commercially available tax
preparation software packages such that it guides the sponsor through
the submission process. Help text, links, embedded guides, and other
aids are intended to assist the user and allow novice 510(k) submitters
to navigate through the process of submitting a 510(k) submission. The
software will consist of textual suggestions and questions designed to
obtain all of the data FDA needs to review the submission and ensure no
required data are omitted. FDA intends to collect data via text fields,
checkboxes, dropdown menus, and, where it would be burdensome to
collect data via these methods, file attachments. For example, FDA
intends to collect much of the administrative data as well as basic
information, such as the Indications for Use, via the software
interface, not via file attachments. However, instruction manuals,
software documentation, performance testing and other large documents
may be attached.
A. Guiding Principles
The following basic principles underline the eSubmissions Pilot
described in this document. CDRH intends that these principles create a
common understanding between the sponsor and CDRH about the goals and
parameters of the eSubmissions Pilot:
1. FDA believes the use of the eSubmission process will result in
administratively complete 510(k) submissions and will not be conducting
a separate acceptance review for the files submitted through the
eSubmissions Pilot.
2. The eSubmission will serve as the only submission required; no
other copies of the submission will be required.
3. The submission of Amendments and Supplements needs to be
completed through the software during the eSubmissions Pilot. FDA
encourages sponsor and reviewer interaction during the review process.
4. FDA will not publicly disclose participation of a sponsor in the
eSubmissions Pilot, unless the sponsor consents or has already made
this information public, or disclosure is required by law.
5. Participating in this eSubmissions Pilot does not guarantee
clearance of a sponsor's 510(k) submission, nor is a sponsor precluded
from withdrawing from the eSubmissions Pilot and pursuing a
conventional 510(k)s submission and review through the current pathway.
6. Due to FDA resource issues, FDA intends to limit the
eSubmissions Pilot to approximately 50 to 100 submissions. FDA may
further limit the number of submissions from an individual firm as
resources and eSubmissions Pilot needs allow.
7. An Extensible Markup Language (XML) Schema Definition (XSD) for
the eSubmissions Pilot template was produced, and FDA intends to allow
future submissions using alternative approaches to eSubmitter (e.g.,
via proprietary software purchased or produced by a medical device
firm), as long as the submission is compliant with the XSD. If FDA
commits to also receiving Regulated Product Submissions (RPS) in the
future, FDA intends to expand this method of receipt to accept RPS
packages. In addition, a different, more modern platform may be used
for future eSubmissions other than eSubmitter.
B. Scope of eSubmissions Pilot
Voluntary participation in the eSubmissions Pilot is open to
sponsors whose submissions are reviewed in ODE's Division of
Cardiovascular Devices Cardiac Diagnostic Devices Branch or Peripheral
Interventional Devices Branch. We encourage 510(k) sponsors of all
device types, including those reviewed in other branches, to review the
software interface and provide feedback via https://www.regulations.gov
or the Division of Dockets Management (see Comments). The eSubmissions
Pilot is limited to unbundled, traditional 510(k) submissions for
classified devices only.\1\
---------------------------------------------------------------------------
\1\ We are not accepting third party 510(k)s or Combination
Products in the eSubmissions Pilot at this time.
---------------------------------------------------------------------------
C. Procedures
The following procedures have been developed to manage the CDRH
eSubmissions Pilot effectively:
1. Under the eSubmissions Pilot, 510(k) submissions will be
reviewed according to CDRH standard procedures.
2. eSubmission will be available for use and submission 24 hours a
day and 7 days a week. However, if a 510(k) is received outside of
normal business hours (Monday to Friday, 8 a.m. to 4:30 p.m. excluding
Federal holidays or dates the Federal Government is shutdown), the
submission receipt date will be considered the next business day.
3. Participation in the eSubmissions Pilot does not affect
submission user fee obligations. If the required user fee is not paid
at the time of submission, the
[[Page 24734]]
receipt date will be the receipt date of a complete User Fee Coversheet
via eSubmission. If a User Fee Coversheet is submitted outside of
normal business hours (Monday to Friday, 8 a.m. to 4:30 p.m. excluding
Federal holidays or dates the Federal Government is shutdown), the User
Fee Coversheet receipt date will be considered the next business day.
4. Volunteers interested in participating in the CDRH 510(k)
eSubmissions Pilot should contact eSubmissions Pilot staff by email at
eSubpilot@fda.hhs.gov. This email address should also be used to report
issues and ask questions. General feedback and comments about the
eSubmissions Pilot, 510(k) template, and process can be provided via
https://www.regulations.gov or the Division of Dockets Management (see
Comments).
5. Additional information on the CDRH 510(k) eSubmissions Pilot is
available at https://www.fda.gov/ForIndustry/FDAeSubmitter/ucm221506.htm.
III. Duration of the eSubmissions Pilot
FDA intends to accept requests for participation in the
eSubmissions Pilot through September 30, 2014, or as resources and
eSubmissions Pilot needs allow. Modifications to the CDRH 510(k)
eSubmissions Pilot will be made available at https://www.fda.gov/ForIndustry/FDAeSubmitter/ucm221506.htm to all eSubmissions Pilot
participants and stakeholders.
IV. Comments
Interested persons may submit electronic comments regarding the
eSubmissions Pilot for CDRH Electronic Submission of Premarket
Notification Submissions to https://www.regulations.gov or written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. It is
only necessary to send one set of comments. Identify comments with the
docket number found in brackets in the 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, and will be posted to
the docket at https://www.regulations.gov.
Dated: April 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09912 Filed 4-30-14; 8:45 am]
BILLING CODE 4160-01-P
