
[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]


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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for Medical Devices, Draft Guidance for Industry and Food and Drug 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.

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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the availability of the draft guidance entitled ``Use of Real-World 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FDA is issuing this draft guidance to clarify how FDA evaluates real-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 This draft guidance 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 This draft guidance is not final nor is it for 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DATES: Submit either electronic or written comments on the draft 
guidance by February 20, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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]]



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                                                            OMB control
    21 CFR part or guidance               Topic                 No.
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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''.
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    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


