[Federal Register Volume 88, Number 244 (Thursday, December 21, 2023)]
[Notices]
[Pages 88395-88396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28095]
-----------------------------------------------------------------------
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Authorization (EUA) Review; Draft Guidance for Industry, Food and Drug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the availability of the draft guidance entitled ``510(k) Third Party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 and Third Party Emergency Use Authorization (EUA)
Review.'' This draft guidance provides FDA's current thinking regarding
the 510(k) Third Party (3P510k) Review Program and review of Emergency
Use Authorizations (EUA) requests by a third party review organizations
(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. This draft guidance is not final nor is it for implementation
at this time.
DATES: Submit either electronic or written comments on the draft
guidance by February 20, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:
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
[[Page 88396]]
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
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 a draft guidance entitled
``510(k) Third Party Review Program and Third Party Emergency Use
Authorization (EUA) Review.'' This draft 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 review EUA requests 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 draft 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
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 draft guidance,
when final, will also outline FDA's current thinking on leveraging the
International Medical Device Regulators Forum's documents for the
3P510k Review Program. When finalized, this guidance will supersede the
final guidance entitled ``510(k) Third Party Review Program; Guidance
for Industry, Food and Drug Administration Staff, and Third Party
Review Organizations'' published in the Federal Register of March 12,
2020 (85 FR 14489).
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 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 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/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.
807, subpart E.................... Premarket 0910-0120
notification.
``Requests for Feedback and Q-submissions and 0910-0756
Meetings for Medical Device Early Payor
Submissions: The Q-Submission Feedback Request
Program''. Programs for
Medical Devices.
``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 Appeals Process..... 0910-0738
and Drug Administration Staff;
Center for Devices and
Radiological Health Appeals
Processes''.
------------------------------------------------------------------------
Dated: December 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28095 Filed 12-20-23; 8:45 am]
BILLING CODE 4164-01-P