510(k) Third Party Review Program and Third Party Emergency Use Authorization Review; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability, 92128-92130 [2024-27085]
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92128
Federal Register / Vol. 89, No. 225 / Thursday, November 21, 2024 / Notices
lotter on DSK11XQN23PROD with NOTICES1
B. Need and Uses
This clearance covers the information
that offerors and contractors must
submit to comply with the following
FAR requirements:
1. FAR 15.407–2(e), Make-or-buy
programs. When prospective contractors
are required to submit proposed makeor-buy program plans for negotiated
acquisitions, paragraph (e) requires the
following information in their proposal:
(a) A description of each major item
or work effort;
(b) Categorization of each major item
or work effort as ‘‘must make,’’ ‘‘must
buy,’’ or ‘‘can either make or buy’’;
(c) For each item or work effort
categorized as ‘‘can either make or buy,’’
a proposal either to ‘‘make’’ or to ‘‘buy’’;
(d) Reasons for categorizing items and
work efforts as ‘‘must make’’ or ‘‘must
buy,’’ and proposing to ‘‘make’’ or to
‘‘buy’’ those categorized as ‘‘can either
make or buy’’;
(e) Designation of the plant or
division proposed to make each item or
perform each work effort, and a
statement as to whether the existing or
proposed new facility is in or near a
labor surplus area;
(f) Identification of proposed
subcontractors, if known, and their
location and size status;
(g) Any recommendations to defer
make-or-buy decisions when
categorization of some items or work
efforts is impracticable at the time of
submission; and
(h) Any other information the
contracting officer requires in order to
evaluate the program.
2. FAR 52.215–1(c)(2)(iv)—
Authorized Negotiators. This provision
requires firms offering supplies or
services to the Government under
negotiated solicitations to provide the
names, titles, and telephone and
facsimile numbers (and electronic
addresses if available) of authorized
negotiators to assure that discussions
are held with authorized individuals.
Contracting officers use this
information during contract negotiations
and it becomes part of the official
contract file.
3. FAR 52.215–9, Changes or
Additions to Make-or-Buy Program.
This clause requires the contractor to
submit, in writing, for the contracting
officer’s advance approval a notification
and justification of any proposed change
in the make-or-buy program
incorporated in the contract.
Contracting officers use the
information collected regarding makeor-buy programs at FAR 15.407–2(e) and
52.215–9 to ensure negotiation of
reasonable contract prices, satisfactory
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performance, or implementation of
socioeconomic policies.
4. FAR 52.215–14—Integrity of Unit
Prices. This clause requires offerors and
contractors under negotiated
solicitations and contracts to identify
those supplies which they will not
manufacture or to which they will not
contribute significant value, if requested
by the contracting officer or when
contracting without adequate price
competition.
When a contract action is priced on
the basis of a cost estimate, contracting
officers use this information to
determine whether the intrinsic value of
an item has been distorted through
allocation of overhead costs and
whether such items should be
considered for breakout.
5. FAR 52.215–19—Notification of
Ownership Changes. This clause
requires contractors to notify the
administrative contracting officer when
the contractor becomes aware that a
change in its ownership has occurred, or
is certain to occur, that could result in
changes in the valuation of its
capitalized assets in the accounting
records.
The notification of ownership change
enables the Government to adequately
administer the cost principle at FAR
31.205–52, Asset valuations resulting
from business combinations, which
addresses the allowability of certain
costs resulting from asset valuations
following business combinations.
6. FAR 52.215–22, Limitations on
Pass-Through Charges—Identification of
Subcontract Effort. This provision
requires offerors submitting a proposal
for a contract, task order, or delivery
order to provide the following
information with their proposal:
(a) The total cost of the work to be
performed by the offeror, and the total
cost of the work to be performed by each
subcontractor;
(b) If the offeror intends to
subcontract more than 70 percent of the
total cost of work to be performed, the
amount of the offeror’s indirect costs
and profit/fee applicable to the work to
be performed by the subcontractor(s),
and a description of the value added by
the offeror as related to the work to be
performed by the subcontractor(s); and
(c) If any subcontractor proposed
intends to subcontract to a lower-tier
subcontractor more than 70 percent of
the total cost of work to be performed,
the amount of the subcontractor’s
indirect costs and profit/fee applicable
to the work to be performed by the
lower-tier subcontractor(s) and a
description of the added value provided
by the subcontractor as related to the
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work to be performed by the lower-tier
subcontractor(s).
7. FAR 52.215–23, Limitations on
Pass-Through Charges. This clause
requires contractors to provide a
description of the value added by the
contractor or subcontractor, as
applicable, as related to the subcontract
effort if the effort changes from the
amount identified in the proposal such
that it exceeds 70 percent of the total
cost of work to be performed.
Contracting officers use the
information collected at FAR 52.215–22
and 52.215–23 to assess the value added
by a contractor or subcontractor in
relation to proposed, billed, or claimed
indirect costs or profit/fee on work
performed by a subcontractor. This
information is required to ensure that
pass-through charges under contracts
and subcontracts are not excessive.
C. Annual Burden
Respondents: 122,097.
Total Annual Responses: 139,074.
Total Burden Hours: 43,027 (43,022
reporting hours + 5 recordkeeping
hours).
Obtaining Copies: Requesters may
obtain a copy of the information
collection documents from the GSA
Regulatory Secretariat Division by
calling 202–501–4755 or emailing
GSARegSec@gsa.gov. Please cite OMB
Control No. 9000–0048, Certain Federal
Acquisition Regulation Part 15
Requirements.
Janet Fry,
Director, Federal Acquisition Policy Division,
Office of Governmentwide Acquisition Policy,
Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2024–27314 Filed 11–20–24; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2565]
510(k) Third Party Review Program and
Third Party Emergency Use
Authorization Review; Guidance for
Industry, Food and Drug
Administration Staff, and Third Party
Review Organizations; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘510(k) Third Party
SUMMARY:
E:\FR\FM\21NON1.SGM
21NON1
Federal Register / Vol. 89, No. 225 / Thursday, November 21, 2024 / Notices
Review Program and Third Party
Emergency Use Authorization (EUA)
Review.’’ This guidance provides FDA’s
current thinking regarding the 510(k)
Third Party (3P510k) Review Program
and review of EUA requests by a third
party review organization (3PEUA
review). The 3P510k Review Program
and 3PEUA review create an alternative
process for manufacturers to seek
review of 510(k) submissions and EUA
requests to assist FDA in reviewing in
a timely manner.
DATES: The announcement of the
guidance is published in the Federal
Register on November 21, 2024.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances 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’’).
lotter on DSK11XQN23PROD with NOTICES1
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.’’
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18:02 Nov 20, 2024
Jkt 265001
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–2565 for ‘‘510(k) Third Party
Review Program and Third Party
Emergency Use Authorization (EUA)
Review.’’ 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, 240–402–7500.
• 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
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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
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
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92129
single hard copy of the guidance
document entitled ‘‘510(k) Third Party
Review Program and Third Party
Emergency Use Authorization (EUA)
Review’’ to the Office of Policy, 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:
Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2438, Silver Spring,
MD 20993–0002, 301–796–6524.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
the ‘‘510(k) Third Party Review Program
and Third Party Emergency Use
Authorization (EUA) Review’’ guidance.
This guidance updates the previously
issued ‘‘510(k) Third Party Review
Program’’ guidance to further clarify the
3P510k Review Program and outline
how FDA may use third party review
organizations to conduct an initial
review of EUA requests for all devices,
including in vitro diagnostics, under
section 564 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360bbb–3) and consistent with section
565(i) of the FD&C Act (21 U.S.C.
360bbb–4(i)).
This guidance distinguishes FDA’s
expectations for the 3P510k Review
Program and for 3PEUA review;
describes the factors FDA will use in
determining device type eligibility for
review by 3P510k Review
Organizations; describes FDA’s
expectations for third party review
organizations when conducting
substantial reviews of 510(k)
submissions and EUA requests; outlines
FDA’s process for the recognition,
rerecognition, suspension, and
withdrawal of recognition for 3P510k
Review Organizations; and describes the
expectations regarding compensation to
third party review organizations. This
guidance also outlines FDA’s current
thinking on leveraging the International
Medical Device Regulators Forum’s
documents for the 3P510k Review
Program. This guidance supersedes
‘‘510(k) Third Party Review Program;
Guidance for Industry, Food and Drug
Administration Staff, and Third Party
Review Organizations’’ issued on March
12, 2020 (85 FR 14489).
A notice of availability of the draft
guidance appeared in the Federal
Register of December 21, 2023 (88 FR
E:\FR\FM\21NON1.SGM
21NON1
92130
Federal Register / Vol. 89, No. 225 / Thursday, November 21, 2024 / Notices
88395). FDA considered comments
received and revised the guidance as
appropriate in response to the
comments, including clarifying the
relationship between 510k Review
Organizations and EUA Third Party
Review Organizations, and conflicts of
interest requirements for personnel of
Third Party Review Organizations.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on 510(k) Third Party
Review Program and Third Party
Emergency Use Authorization (EUA)
Review. 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
II. 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/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov and https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents.
Persons unable to download an
electronic copy of ‘‘510(k) Third Party
Review Program and Third Party
Emergency Use Authorization (EUA)
Review’’ may send an email request to
CDRH-Guidance@fda.hhs.gov to receive
an electronic copy of the document.
Please use the document number
GUI01500013 and complete title to
identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in the following table have
been approved by OMB:
OMB control
No.
21 CFR part; guidance; or FDA form
Topic
‘‘510(k) Third Party Review Program’’ .......................................
‘‘Requests for Feedback on Medical Device Submissions: The
Pre-Submission Program and Meetings with Food and Drug
Administration Staff’’.
‘‘Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders’’.
‘‘Guidance for Industry and Food and Drug Administration
Staff; Center for Devices and Radiological Health Appeals
Processes’’.
510(k) Third Party Review Program ...........................................
Q-submissions ............................................................................
0910–0375
0910–0756
Emergency Use Authorization ....................................................
0910–0595
CDRH Appeals Processes .........................................................
0910–0738
Dated: November 12, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–27085 Filed 11–20–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3609]
Development of an Enhanced
Systematic Process for the Food and
Drug Administration’s Post-Market
Assessment of Chemicals in Food;
Public Meeting; Request for
Comments; Extension of Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
lotter on DSK11XQN23PROD with NOTICES1
requirements of the applicable statutes
and regulations.
Notice of public meeting;
request for comments; extension of
comment period.
ACTION:
The Food and Drug
Administration (FDA or we) is
extending the comment period for the
notice of public meeting; request for
SUMMARY:
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18:02 Nov 20, 2024
Jkt 265001
comments, published in the Federal
Register of August 12, 2024. In that
notice, FDA announced a public
meeting entitled ‘‘Development of an
Enhanced Systematic Process for the
Food and Drug Administration’s PostMarket Assessment of Chemicals in
Food.’’ FDA hosted the public meeting
on September 25, 2024, and is now
extending the comment period to allow
interested persons additional time to
submit comments about approaches to
systematic post-market assessment of
chemicals in food.
DATES: FDA is extending the comment
period announced in the notice of
public meeting; request for comments
published August 12, 2024 (89 FR
65633). Either electronic or written
comments must be submitted by January
21, 2025.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
January 21, 2025. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
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timely if they are received on or before
that date.
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
E:\FR\FM\21NON1.SGM
21NON1
]]>Agencies
[Federal Register Volume 89, Number 225 (Thursday, November 21, 2024)]
[Notices]
[Pages 92128-92130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27085]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-2565]
510(k) Third Party Review Program and Third Party Emergency Use
Authorization Review; 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 a final guidance entitled ``510(k) Third Party
[[Page 92129]]
Review Program and Third Party Emergency Use Authorization (EUA)
Review.'' This guidance provides FDA's current thinking regarding the
510(k) Third Party (3P510k) Review Program and review of EUA requests
by a third party review organization (3PEUA review). The 3P510k Review
Program and 3PEUA review create an alternative process for
manufacturers to seek review of 510(k) submissions and EUA requests to
assist FDA in reviewing in a timely manner.
DATES: The announcement of the guidance is published in the Federal
Register on November 21, 2024.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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 and Third Party
Emergency Use Authorization (EUA) Review.'' 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, 240-402-7500.
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 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.govinfo.gov/content/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, 240-402-7500.
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 guidance document entitled
``510(k) Third Party Review Program and Third Party Emergency Use
Authorization (EUA) Review'' to the Office of Policy, 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: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2438, Silver Spring, MD 20993-0002, 301-796-6524.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of the ``510(k) Third Party
Review Program and Third Party Emergency Use Authorization (EUA)
Review'' guidance. This guidance updates the previously issued ``510(k)
Third Party Review Program'' guidance to further clarify the 3P510k
Review Program and outline how FDA may use third party review
organizations to conduct an initial review of EUA requests for all
devices, including in vitro diagnostics, under section 564 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3)
and consistent with section 565(i) of the FD&C Act (21 U.S.C. 360bbb-
4(i)).
This guidance distinguishes FDA's expectations for the 3P510k
Review Program and for 3PEUA review; describes the factors FDA will use
in determining device type eligibility for review by 3P510k Review
Organizations; describes FDA's expectations for third party review
organizations when conducting substantial reviews of 510(k) submissions
and EUA requests; outlines FDA's process for the recognition,
rerecognition, suspension, and withdrawal of recognition for 3P510k
Review Organizations; and describes the expectations regarding
compensation to third party review organizations. This guidance also
outlines FDA's current thinking on leveraging the International Medical
Device Regulators Forum's documents for the 3P510k Review Program. This
guidance supersedes ``510(k) Third Party Review Program; Guidance for
Industry, Food and Drug Administration Staff, and Third Party Review
Organizations'' issued on March 12, 2020 (85 FR 14489).
A notice of availability of the draft guidance appeared in the
Federal Register of December 21, 2023 (88 FR
[[Page 92130]]
88395). FDA considered comments received and revised the guidance as
appropriate in response to the comments, including clarifying the
relationship between 510k Review Organizations and EUA Third Party
Review Organizations, and conflicts of interest requirements for
personnel of Third Party Review Organizations.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on 510(k) Third Party Review Program and Third
Party Emergency Use Authorization (EUA) Review. 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.
II. 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``510(k) Third Party Review Program and
Third Party Emergency Use Authorization (EUA) Review'' may send an
email request to [email protected] to receive an electronic
copy of the document. Please use the document number GUI01500013 and
complete title to identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in the following table have been approved by OMB:
------------------------------------------------------------------------
OMB control
21 CFR part; guidance; or FDA form Topic No.
------------------------------------------------------------------------
``510(k) Third Party Review 510(k) Third Party 0910-0375
Program''. Review Program.
``Requests for Feedback on Medical Q-submissions....... 0910-0756
Device Submissions: The Pre-
Submission Program and Meetings
with Food and Drug Administration
Staff''.
``Emergency Use Authorization of Emergency Use 0910-0595
Medical Products and Related Authorization.
Authorities; Guidance for
Industry and Other Stakeholders''.
``Guidance for Industry and Food CDRH Appeals 0910-0738
and Drug Administration Staff; Processes.
Center for Devices and
Radiological Health Appeals
Processes''.
------------------------------------------------------------------------
Dated: November 12, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-27085 Filed 11-20-24; 8:45 am]
BILLING CODE 4164-01-P
