[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Notices]
[Pages 87782-87784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27852]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-4395]
Use of Real-World Evidence To Support Regulatory Decision-Making
for Medical Devices, Draft Guidance for Industry and Food and Drug
Administration Staff; 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the availability of the draft guidance entitled ``Use of Real-World
Evidence to Support Regulatory Decision-Making for Medical Devices.''
FDA is issuing this draft guidance to clarify how FDA evaluates real-
world data (RWD) to determine whether they are of sufficient quality
for generating real-world evidence (RWE) that can be used in FDA
regulatory decision-making for medical devices. This draft guidance
proposes expanded recommendations to the 2017 guidance entitled ``Use
of Real-World Evidence to Support Regulatory Decision-Making for
Medical Devices.'' This draft guidance is not final nor is it for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DATES: Submit either electronic or written comments on the draft
guidance by February 20, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-2023-D-4395 for ``Use of Real-World Evidence to Support Regulatory
Decision-Making for Medical Devices.'' 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
[[Page 87783]]
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 draft guidance document entitled
``Use of Real-World Evidence to Support Regulatory Decision-Making for
Medical Devices'' 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; or to Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT: Soma Kalb, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 318, Silver Spring, MD 20993-0002, 301-796-6359; or
James Myers, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing this draft guidance to clarify how FDA evaluates RWD
to determine whether they are of sufficient quality for generating RWE
that can be used in FDA regulatory decision-making for medical devices.
This draft guidance proposes expanded recommendations to the 2017
guidance entitled ``Use of Real-World Evidence to Support Regulatory
Decision-Making for Medical Devices'' (the 2017 RWE Guidance). On
December 29, 2022, the Food and Drug Omnibus Reform Act of 2022 (FDORA)
was signed into law as part of the Consolidated Appropriations Act,
2023 (Pub. L. 117-328). Section 3629 of FDORA ``Facilitating the Use of
Real World Evidence'' directs FDA to issue or revise existing guidance
on considerations for the use of RWD and RWE to support regulatory
decision making. FDA is issuing this draft guidance to propose
revisions to the 2017 RWE Guidance to satisfy the requirement under
section 3629(a)(2). This draft guidance also fulfills a commitment in
section V.F. of the Medical Device User Fee Amendments Performance
Goals and Procedures, Fiscal Years 2023 Through 2027 (MDUFA V).
This draft guidance includes FDA's recommendations and
considerations on the factors that are expected to be assessed to
demonstrate whether the RWD are fit-for-purpose for a particular
regulatory decision relating to medical devices. When this draft
guidance is finalized, these recommendations and considerations will
apply regardless of the RWD source and will encompass processes for
conducting studies to generate RWE. A fit-for-purpose assessment should
evaluate both the relevance and reliability of a RWD source, as
discussed in more detail in the draft guidance. FDA recognizes that
there may be other approaches to address the considerations identified
in this draft guidance. We encourage sponsors to discuss their approach
with FDA, especially if the approach diverges from the recommendations
in this draft guidance, when finalized.
The topics covered within this draft guidance are framed
specifically for the use of RWD/RWE in regulatory submissions. This
draft guidance includes additional clarity regarding the recommended
methodologies for collection and analysis of RWD to generate RWE, and
provides updated examples on previously used and accepted
methodologies. This draft guidance also provides additional clarity
regarding the use of clinical data collected from the use of a device
authorized under an Emergency Use Authorization (EUA) and to describe
the type of information that could be applicable to support a
determination under the Clinical Laboratory Improvement Amendments
(CLIA) (e.g., Waiver by Application).
FDA recognizes and anticipates that the Agency and industry may
need up to 60 days to perform activities to operationalize the
recommendations within the final guidance. At this time, the Agency
anticipates that, for regulatory submissions that will be currently
pending with FDA after publication of the final guidance, as well as
those submissions received within 60 days following publication of the
final guidance, FDA generally would not anticipate that sponsors will
be ready to include the newly recommended information outlined in the
final guidance in their submission. FDA, however, would intend to
review any such information if submitted at any time.
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 ``Use of Real-
World Evidence to Support Regulatory Decision-Making for Medical
Devices.'' 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, https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of
``Use of Real-World Evidence to Support Regulatory Decision-Making for
Medical Devices'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number GUI00500012 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 (44 U.S.C. 3501-3521). The collections of information in the
following table have been approved by OMB:
[[Page 87784]]
------------------------------------------------------------------------
OMB control
21 CFR part or guidance Topic No.
------------------------------------------------------------------------
807, subpart E................. Premarket notification. 0910-0120
814, subparts A through E...... Premarket approval..... 0910-0231
814, subpart H................. Humanitarian Use 0910-0332
Devices; Humanitarian
Device Exemption.
812............................ Investigational Device 0910-0078
Exemption.
860, subpart D................. De Novo classification 0910-0844
process.
``Requests for Feedback and Q-Submissions and Early 0910-0756
Meetings for Medical Device Payor Feedback Request
Submissions: The Q-Submission Programs for Medical
Program''. Devices.
822............................ Postmarket Surveillance 0910-0449
of Medical Devices.
50, 56......................... Protection of Human 0910-0130
Subjects and
Institutional Review
Boards.
601............................ Biologics License 0910-0338
Application.
803............................ Medical Device 0910-0437
Reporting.
``Administrative Procedures for CLIA Administrative 0910-0607
CLIA Categorization'' and Procedures; CLIA
``Recommendations: Clinical Waivers.
Laboratory Improvement
Amendments of 1988 (CLIA)
Waiver Applications for
Manufacturers of In Vitro
Diagnostic Devices''.
800, 801, 809, and 830......... Medical Device Labeling 0910-0485
Requirements; Unique
Device Identification.
860............................ Reclassification 0910-0138
Petition for Medical
Devices.
``Emergency Use Authorization EUA.................... 0910-0595
of Medical Products and
Related Authorities''.
------------------------------------------------------------------------
Dated: December 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27852 Filed 12-18-23; 8:45 am]
BILLING CODE 4164-01-P