510(k) Third-Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third-Party Review Organizations; Availability, 46742-46745 [2018-19992]
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Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices
• Title of the standard;
• Any reference number and date;
• Proposed list of devices for which
a declaration of conformity should
routinely apply;
• Basis for recognition, e.g., including
the scientific, technical, regulatory, or
other basis for such request; and
• A brief identification of the testing
or performance or other characteristics
and rationales for withdrawing a
standard. The guidance also provides
that any interested party may request
recognition of a standard. The draft
guidance recommends that for
recognition of a standard the request
should, at a minimum, contain the
following information:
• Name and electronic or mailing
address of the requestor;
of the device(s) or process(es), that
would be addressed by a declaration of
conformity.
Based on previous requests for
recognition of standards, we estimate
that FDA will receive nine requests
annually. We estimate that each request
will take less than 1 hour to prepare.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Request for recognition of a voluntary consensus standard
9
1
9
1
9
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
V. Reference
The following reference is on display
with the Dockets Management Staff (see
ADDRESSES) and is available for viewing
by interested persons between 9 a.m.
and 4 p.m., Monday through Friday; it
is also available electronically at https://
www.regulations.gov. FDA has verified
the website address, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. OMB, ‘‘Federal Participation in the
Development and Use of Voluntary
Consensus Standards and in Conformity
Assessment Activities,’’ Circular A–119
(revised). January 22, 2016. Available at:
https://www.nist.gov/sites/default/files/
revised_circular_a-119_as_of_01-222016.pdf.
Dated: September 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19993 Filed 9–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2565]
510(k) Third-Party Review Program;
Draft Guidance for Industry, Food and
Drug Administration Staff, and ThirdParty Review Organizations;
Availability
daltland on DSKBBV9HB2PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘510(k) Third-Party
Review Program; Draft Guidance for
SUMMARY:
VerDate Sep<11>2014
17:06 Sep 13, 2018
Jkt 244001
Industry, Food and Drug Administration
Staff, and Third-Party Review
Organizations.’’ This draft guidance
provides a comprehensive look into
FDA’s current thinking regarding the
510(k) Third-Party (3P) Review Program
authorized under the Federal Food,
Drug, and Cosmetic Act (FD&C Act).
Under the FDA Reauthorization Act of
2017 (FDARA), FDA was directed to
issue draft guidance on the factors that
will be used in determining whether a
class I or class II device type, or subset
of such device types, is eligible for
review by an accredited person. The 3P
Review Program is intended to allow
review of devices by 3P Review
Organizations to provide manufacturers
of these devices an alternative review
process that allows FDA to best utilize
our resources on higher risk devices.
This draft guidance is not final nor is it
in effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by December 13, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
Submit either electronic or written
comments on the collection of
information by November 13, 2018.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
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confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–2565 for ‘‘510(k) Third-Party
Review Program.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
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Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘510(k) Third-Party
Review Program’’ to the Office of the
Center Director, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Gregory Pishko, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
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17:06 Sep 13, 2018
Jkt 244001
Ave., Bldg. 66, Rm. 5659, Silver Spring,
MD 20993–0002, 240–402–6635.
SUPPLEMENTARY INFORMATION:
I. Background
FDA’s implementation of section 523
of the FD&C Act (21 U.S.C. 360m)
establishes a process for recognition of
qualified third parties to conduct the
initial review of premarket notification
(510(k)) submissions for certain low-tomoderate risk devices eligible under the
3P Review Program. Under FDARA
(Pub. L. 115–52), the criteria used to
establish device eligibility in the 3P
Review Program changed and FDA was
directed to issue draft guidance on the
factors that will be used in determining
whether a class I or class II device type,
or subset of such device types, is
eligible for review by an accredited
person. The objectives of this draft
guidance are: (1) To describe the factors
FDA will use in determining device
type eligibility for review by 3P Review
Organizations; (2) to outline FDA’s
process for the recognition, rerecognition, suspension, and
withdrawal of recognition for 3P Review
Organizations; and (3) to ensure
consistent quality of work among 3P
Review Organizations through Medical
Device User Fee Amendments IV
commitments authorized under FDARA.
This draft guidance also outlines FDA’s
current thinking on leveraging the
International Medical Device Regulators
Forum’s requirements for the Medical
Device Single Audit Program.
Upon issuance, this draft guidance
will replace the draft guidance entitled
‘‘510(k) Third-Party Review Program—
Draft Guidance for Industry, Food and
Drug Administration Staff, and ThirdParty Review Organizations’’ (81 FR
62744) issued on September 12, 2016.
This draft guidance, when finalized,
will supersede ‘‘Implementation of
Third-Party Programs Under the FDA
Modernization Act of 1997; Final
Guidance for Staff, Industry, and Third
Parties’’ issued on February 2, 2001, and
‘‘Guidance for Third Parties and FDA
Staff; Third-Party Review of Premarket
Notifications’’ issued on September 28,
2004.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on the ‘‘510(k) Third-Party Review
Program.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
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46743
and regulations. This guidance is not
subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy
of the draft 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. This
guidance document is also available at
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘510(k) Third-Party Review Program’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 17–028 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
Under the PRA (44 U.S.C. 3501–
3520), Federal Agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
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.
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510(k) Third-Party Review Program
(Formerly Medical Devices; Third-Party
Review Under the Food and Drug
Administration Modernization Act)
OMB Control Number 0910–0375—
Revision
Information collections (ICs)
associated with the 510(k) Third-Party
Review Program have been approved
under OMB control number 0910–0375,
‘‘Medical Devices; Third-Party Review
Under the Food and Drug
Administration Modernization Act.’’
When finalized, the draft guidance
entitled ‘‘510(k) Third-Party Review
Program; Draft Guidance for Industry,
Food and Drug Administration Staff,
and Third-Party Review Organizations’’
will necessitate revisions to the burden
estimates in OMB control number 0910–
0375.
Section 210 of the Food and Drug
Administration Modernization Act
(FDAMA) established section 523 of the
FD&C Act (21 U.S.C. 360m), directing
FDA to accredit persons in the private
sector to review certain premarket
notifications (510(k)s). Participation in
this third-party review program by
accredited persons is entirely voluntary.
A third party wishing to participate will
submit a request for accreditation to
FDA. Accredited third-party reviewers
have the ability to review a
manufacturer’s 510(k) submission for
selected devices. After reviewing a
submission, the reviewer will forward a
copy of the 510(k) submission, along
with the reviewer’s documented review
and recommendation, to FDA. Thirdparty reviewers should maintain records
of their 510(k) reviews and a copy of the
510(k) for a reasonable period of time,
usually a period of 3 years.
Respondents to this information
collection are businesses or other forprofit organizations.
FDA estimates the burden of this IC
as follows:
Estimated Annual Reporting Burden
Requests for accreditation (initial): On
average, the Agency has received one
application for accreditation for 3P
review per year. There is no change to
this IC from the currently approved
burden estimate.
Requests for accreditation (rerecognition): We have added an IC for
re-recognition requests to be consistent
with the guidance which states that
requests for re-recognition will be
handled in the same manner as initial
recognition requests. Based on the
estimated number of 3P Review
Organizations (7) and the frequency of
re-recognition (3 years), we expect to
receive approximately 2 re-recognition
requests per year. We expect the average
burden per response to be the same as
an initial request (24 hours).
510(k) reviews conducted by
accredited third parties: Based on FDA’s
recent experience with this program, we
estimate the number of 510(k)s
submitted for third-party review to be
147 annually; approximately 21 annual
reviews for each of the 7 3P Review
Organizations. This IC has been
adjusted based on current trends,
however, there is no program change to
this IC.
Complaints: The guidance
recommends that the 3P Review
Organization should forward to FDA
information on any complaint (e.g.,
whistleblowing) it receives about a
510(k) submitter that could indicate an
issue related to the safety or
effectiveness of a medical device or a
public health risk. Therefore, we have
added an IC for complaints to the
reporting burden. We expect to receive
one forwarded complaint per year.
Based on similar information
collections, we estimate the average
burden per complaint to be 0.25 hours
(15 minutes).
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Average
burden per
response
Total hours
Requests for accreditation (initial) 3 .....................................
Requests for accreditation (re-recognition) 5 .......................
510(k) reviews conducted by accredited third parties 4 .......
Complaints 5 .........................................................................
1
2
7
1
1
1
21
1
1
2
147
1
24
24
40
0.25
24
48
5,880
1
Total ..............................................................................
........................
........................
........................
........................
5,952
1 There
are no capital costs or operating and maintenance costs associated with this IC.
(15 minutes)
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Estimated Annual Recordkeeping
Burden
510(k) Reviews: 3P Review
Organizations should retain copies of all
510(k) reviews and associated
correspondence. Based on FDA’s recent
experience with this program, we
estimate the number of 510(k)s
submitted for 3P review to be 147
annually; approximately 21 annual
reviews for each of the 7 3P Review
Organizations. We estimate the average
burden per recordkeeping to be 10
hours. The estimated number of records
and recordkeepers have been adjusted
based on current trends, however, there
is no program change to this IC.
Records regarding qualifications to
receive FDA recognition as a 3P Review
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Organization: Under section 704(f) of
the FD&C Act (21 U.S.C. 374(f)), a 3P
Review Organization must maintain
records that support their initial and
continuing qualifications to receive FDA
recognition, including documentation of
the training and qualifications of the 3P
Review Organization and its personnel;
the procedures used by the 3P Review
Organization for handling confidential
information; the compensation
arrangements made by the 3P Review
Organization; and the procedures used
by the 3P Review Organization to
identify and avoid conflicts of interest.
Additionally, the draft guidance states
that 3P Review Organizations should
retain information on the identity and
qualifications of all personnel who
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contributed to the technical review of
each 510(k) submission and other
relevant records. Therefore, we have
added an IC for ‘‘Records regarding
qualification to receive FDA recognition
as a 3P Review Organization.’’ Because
most of the burden of compiling the
records is expressed in the reporting
burden for requests for accreditation, we
estimate the maintenance of such
records to be 1 hour per recordkeeping
annually.
Recordkeeping system regarding
complaints: Section 523(b)(3)(E)(iv) of
the FD&C Act requires 3P Review
Organizations to agree in writing that
they will promptly respond and attempt
to resolve complaints regarding their
activities. The draft guidance
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Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices
recommends that 3P Review
Organizations establish a recordkeeping
system for tracking the submission of
those complaints and how those
complaints were resolved, or attempted
to be resolved. Therefore, we have
added an IC for ‘‘Recordkeeping system
regarding complaints.’’ Based on our
experience with the program and the
recommendations in the guidance, we
estimate the average burden per
recordkeeping to be 2 hours.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Average
burden per
recordkeeping
Total annual
records
Total hours
510(k) reviews 3 ...................................................................
Records regarding qualifications to receive FDA recognition as a 3P Review Organization 4 .................................
Recordkeeping system regarding complaints 4 ...................
7
21
147
10
1,470
7
7
1
1
7
7
1
2
7
14
Total ..............................................................................
........................
........................
........................
........................
1,491
1 There
are no capital costs or operating and maintenance costs associated with this IC.
We revised our estimates for OMB
control number 0910–0375 by adding
new ICs, changing the title of the ICR,
and adjusting the existing ICs based on
current trends. Despite the addition of
new ICs, the estimated burden reflects
an overall decrease of 5,581 hours. We
attribute this adjustment to a decrease in
the number of submissions we received
over the last few years.
The draft guidance also refers to
previously approved ICs found in FDA
regulations. The ICs in 21 CFR part 807,
subpart E have been approved under
OMB control number 0910–0120; the
ICs regarding 3P Review of medical
devices under FDAMA have been
approved under OMB control number
0910–0375; the ICs for the device
appeals processes have been approved
under OMB control number 0910–0738;
the ICs in the guidance document
‘‘Requests for Feedback on Medical
Device Submissions: The PreSubmission Program and Meetings with
Food and Drug Administration Staff’’
have been approved under OMB control
number 0910–0756.
Dated: September 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Product-Specific Guidances; Draft and
Revised Draft Guidances for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
VerDate Sep<11>2014
17:06 Sep 13, 2018
Jkt 244001
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of
additional draft and revised draft
product-specific guidances. The
guidances provide product-specific
recommendations on, among other
things, the design of bioequivalence
(BE) studies to support abbreviated new
drug applications (ANDAs). In the
Federal Register of June 11, 2010, FDA
announced the availability of a guidance
for industry entitled ‘‘Bioequivalence
Recommendations for Specific
Products’’ that explained the process
that would be used to make productspecific guidances available to the
public on FDA’s website. The guidances
identified in this notice were developed
using the process described in that
guidance.
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by November 13, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:
Electronic Submissions
[FR Doc. 2018–19992 Filed 9–13–18; 8:45 am]
daltland on DSKBBV9HB2PROD with NOTICES
Number of
records per
recordkeeper
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
PO 00000
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that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2007–D–0369 for ‘‘Product-Specific
Guidances; Draft and Revised Draft
Guidances for Industry.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
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]]>Agencies
[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)]
[Notices]
[Pages 46742-46745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19992]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-2565]
510(k) Third-Party Review Program; Draft Guidance for Industry,
Food and Drug Administration Staff, and Third-Party Review
Organizations; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``510(k) Third-Party
Review Program; Draft Guidance for Industry, Food and Drug
Administration Staff, and Third-Party Review Organizations.'' This
draft guidance provides a comprehensive look into FDA's current
thinking regarding the 510(k) Third-Party (3P) Review Program
authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Under the FDA Reauthorization Act of 2017 (FDARA), FDA was directed to
issue draft guidance on the factors that will be used in determining
whether a class I or class II device type, or subset of such device
types, is eligible for review by an accredited person. The 3P Review
Program is intended to allow review of devices by 3P Review
Organizations to provide manufacturers of these devices an alternative
review process that allows FDA to best utilize our resources on higher
risk devices. This draft guidance is not final nor is it in effect at
this time.
DATES: Submit either electronic or written comments on the draft
guidance by December 13, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit either electronic or written comments
on the collection of information by November 13, 2018.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-D-2565 for ``510(k) Third-Party Review Program.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be
[[Page 46743]]
made publicly available, submit your comments only as a written/paper
submission. You should submit two copies total. One copy will include
the information you claim to be confidential with a heading or cover
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.''
The Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``510(k) Third-Party Review Program'' to the Office of the Center
Director, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT: Gregory Pishko, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5659, Silver Spring, MD 20993-0002, 240-402-6635.
SUPPLEMENTARY INFORMATION:
I. Background
FDA's implementation of section 523 of the FD&C Act (21 U.S.C.
360m) establishes a process for recognition of qualified third parties
to conduct the initial review of premarket notification (510(k))
submissions for certain low-to-moderate risk devices eligible under the
3P Review Program. Under FDARA (Pub. L. 115-52), the criteria used to
establish device eligibility in the 3P Review Program changed and FDA
was directed to issue draft guidance on the factors that will be used
in determining whether a class I or class II device type, or subset of
such device types, is eligible for review by an accredited person. The
objectives of this draft guidance are: (1) To describe the factors FDA
will use in determining device type eligibility for review by 3P Review
Organizations; (2) to outline FDA's process for the recognition, re-
recognition, suspension, and withdrawal of recognition for 3P Review
Organizations; and (3) to ensure consistent quality of work among 3P
Review Organizations through Medical Device User Fee Amendments IV
commitments authorized under FDARA. This draft guidance also outlines
FDA's current thinking on leveraging the International Medical Device
Regulators Forum's requirements for the Medical Device Single Audit
Program.
Upon issuance, this draft guidance will replace the draft guidance
entitled ``510(k) Third-Party Review Program--Draft Guidance for
Industry, Food and Drug Administration Staff, and Third-Party Review
Organizations'' (81 FR 62744) issued on September 12, 2016.
This draft guidance, when finalized, will supersede
``Implementation of Third-Party Programs Under the FDA Modernization
Act of 1997; Final Guidance for Staff, Industry, and Third Parties''
issued on February 2, 2001, and ``Guidance for Third Parties and FDA
Staff; Third-Party Review of Premarket Notifications'' issued on
September 28, 2004.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the ``510(k)
Third-Party Review Program.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.
III. Electronic Access
Persons interested in obtaining a copy of the draft 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. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``510(k) Third-Party
Review Program'' may send an email request to [email protected]
to receive an electronic copy of the document. Please use the document
number 17-028 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain
approval from the Office of Management and Budget (OMB) for each
collection of information they conduct or sponsor. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes Agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
Federal Agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
With respect to the following 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.
[[Page 46744]]
510(k) Third-Party Review Program (Formerly Medical Devices; Third-
Party Review Under the Food and Drug Administration Modernization Act)
OMB Control Number 0910-0375--Revision
Information collections (ICs) associated with the 510(k) Third-
Party Review Program have been approved under OMB control number 0910-
0375, ``Medical Devices; Third-Party Review Under the Food and Drug
Administration Modernization Act.'' When finalized, the draft guidance
entitled ``510(k) Third-Party Review Program; Draft Guidance for
Industry, Food and Drug Administration Staff, and Third-Party Review
Organizations'' will necessitate revisions to the burden estimates in
OMB control number 0910-0375.
Section 210 of the Food and Drug Administration Modernization Act
(FDAMA) established section 523 of the FD&C Act (21 U.S.C. 360m),
directing FDA to accredit persons in the private sector to review
certain premarket notifications (510(k)s). Participation in this third-
party review program by accredited persons is entirely voluntary. A
third party wishing to participate will submit a request for
accreditation to FDA. Accredited third-party reviewers have the ability
to review a manufacturer's 510(k) submission for selected devices.
After reviewing a submission, the reviewer will forward a copy of the
510(k) submission, along with the reviewer's documented review and
recommendation, to FDA. Third-party reviewers should maintain records
of their 510(k) reviews and a copy of the 510(k) for a reasonable
period of time, usually a period of 3 years.
Respondents to this information collection are businesses or other
for-profit organizations.
FDA estimates the burden of this IC as follows:
Estimated Annual Reporting Burden
Requests for accreditation (initial): On average, the Agency has
received one application for accreditation for 3P review per year.
There is no change to this IC from the currently approved burden
estimate.
Requests for accreditation (re-recognition): We have added an IC
for re-recognition requests to be consistent with the guidance which
states that requests for re-recognition will be handled in the same
manner as initial recognition requests. Based on the estimated number
of 3P Review Organizations (7) and the frequency of re-recognition (3
years), we expect to receive approximately 2 re-recognition requests
per year. We expect the average burden per response to be the same as
an initial request (24 hours).
510(k) reviews conducted by accredited third parties: Based on
FDA's recent experience with this program, we estimate the number of
510(k)s submitted for third-party review to be 147 annually;
approximately 21 annual reviews for each of the 7 3P Review
Organizations. This IC has been adjusted based on current trends,
however, there is no program change to this IC.
Complaints: The guidance recommends that the 3P Review Organization
should forward to FDA information on any complaint (e.g.,
whistleblowing) it receives about a 510(k) submitter that could
indicate an issue related to the safety or effectiveness of a medical
device or a public health risk. Therefore, we have added an IC for
complaints to the reporting burden. We expect to receive one forwarded
complaint per year. Based on similar information collections, we
estimate the average burden per complaint to be 0.25 hours (15
minutes).
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Requests for accreditation 1 1 1 24 24
(initial) \3\..................
Requests for accreditation (re- 2 1 2 24 48
recognition) \5\...............
510(k) reviews conducted by 7 21 147 40 5,880
accredited third parties \4\...
Complaints \5\.................. 1 1 1 0.25 1
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 5,952
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this IC.
(15 minutes)
Estimated Annual Recordkeeping Burden
510(k) Reviews: 3P Review Organizations should retain copies of all
510(k) reviews and associated correspondence. Based on FDA's recent
experience with this program, we estimate the number of 510(k)s
submitted for 3P review to be 147 annually; approximately 21 annual
reviews for each of the 7 3P Review Organizations. We estimate the
average burden per recordkeeping to be 10 hours. The estimated number
of records and recordkeepers have been adjusted based on current
trends, however, there is no program change to this IC.
Records regarding qualifications to receive FDA recognition as a 3P
Review Organization: Under section 704(f) of the FD&C Act (21 U.S.C.
374(f)), a 3P Review Organization must maintain records that support
their initial and continuing qualifications to receive FDA recognition,
including documentation of the training and qualifications of the 3P
Review Organization and its personnel; the procedures used by the 3P
Review Organization for handling confidential information; the
compensation arrangements made by the 3P Review Organization; and the
procedures used by the 3P Review Organization to identify and avoid
conflicts of interest. Additionally, the draft guidance states that 3P
Review Organizations should retain information on the identity and
qualifications of all personnel who contributed to the technical review
of each 510(k) submission and other relevant records. Therefore, we
have added an IC for ``Records regarding qualification to receive FDA
recognition as a 3P Review Organization.'' Because most of the burden
of compiling the records is expressed in the reporting burden for
requests for accreditation, we estimate the maintenance of such records
to be 1 hour per recordkeeping annually.
Recordkeeping system regarding complaints: Section 523(b)(3)(E)(iv)
of the FD&C Act requires 3P Review Organizations to agree in writing
that they will promptly respond and attempt to resolve complaints
regarding their activities. The draft guidance
[[Page 46745]]
recommends that 3P Review Organizations establish a recordkeeping
system for tracking the submission of those complaints and how those
complaints were resolved, or attempted to be resolved. Therefore, we
have added an IC for ``Recordkeeping system regarding complaints.''
Based on our experience with the program and the recommendations in the
guidance, we estimate the average burden per recordkeeping to be 2
hours.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
510(k) reviews \3\.............. 7 21 147 10 1,470
Records regarding qualifications 7 1 7 1 7
to receive FDA recognition as a
3P Review Organization \4\.....
Recordkeeping system regarding 7 1 7 2 14
complaints \4\.................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,491
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this IC.
We revised our estimates for OMB control number 0910-0375 by adding
new ICs, changing the title of the ICR, and adjusting the existing ICs
based on current trends. Despite the addition of new ICs, the estimated
burden reflects an overall decrease of 5,581 hours. We attribute this
adjustment to a decrease in the number of submissions we received over
the last few years.
The draft guidance also refers to previously approved ICs found in
FDA regulations. The ICs in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120; the ICs regarding 3P
Review of medical devices under FDAMA have been approved under OMB
control number 0910-0375; the ICs for the device appeals processes have
been approved under OMB control number 0910-0738; the ICs in the
guidance document ``Requests for Feedback on Medical Device
Submissions: The Pre-Submission Program and Meetings with Food and Drug
Administration Staff'' have been approved under OMB control number
0910-0756.
Dated: September 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19992 Filed 9-13-18; 8:45 am]
BILLING CODE 4164-01-P
