Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2023-D-4395]</DEPDOC> <SUBJECT>Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice of availability. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance entitled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” FDA is issuing this 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 final guidance supersedes the final guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” issued August 31, 2017, and provides expanded and updated recommendations. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> The announcement of the guidance is published in the <E T="04">Federal Register</E> on December 18, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> You may submit either electronic or written comments on Agency guidances at any time as follows: <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal:</E> <E T="03">https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> 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 <E T="03">https://www.regulations.gov.</E> • 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”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> 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.” <E T="03">Instructions:</E> 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 <E T="03">https://www.regulations.gov</E> 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 <E T="03">https://www.regulations.gov.</E> 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: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> 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 <E T="02">SUPPLEMENTARY INFORMATION</E> section for information on electronic access to the guidance. Submit written requests for a single hard copy of the 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. 5441, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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 Phillip Kurs, Center for Biologics Evaluation and Research, Food and Drug Administration, 240-402-7911. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> FDA is issuing this 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 guidance provides expanded and updated recommendations to the 2017 guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” (the 2017 RWE Guidance) and supersedes 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, Public Law 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 issued the draft guidance on December 19, 2023, to propose revisions to the 2017 RWE Guidance to satisfy the requirement under section 3629(a)(2), and is finalizing this guidance to fulfill 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 guidance includes FDA's recommendations and considerations on the factors that sponsors should assess to demonstrate whether the RWD are relevant and reliable for a particular regulatory decision relating to medical devices. These recommendations and considerations apply regardless of the RWD source and encompass processes for conducting studies to generate RWE. FDA recognizes that there may be other approaches to address the considerations identified in this guidance. We encourage sponsors to discuss their approach with FDA, especially if the approach diverges from the recommendations in this guidance. The topics covered within this guidance are framed specifically for the use of RWD/RWE in regulatory submissions. This 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 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 describes the type of information that could be applicable to support a determination under the Clinical Laboratory Improvement Amendments (CLIA) ( <E T="03">e.g.,</E> 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 this final guidance. For regulatory submissions that will be currently pending with FDA after publication of this final guidance, as well as those submissions received within 60 days following publication of this final guidance, FDA generally does not anticipate that sponsors will be ready to include the newly recommended information outlined in this final guidance in their submission. FDA, however, intends to review any such information if submitted at any time. A notice of availability of the draft guidance appeared in the <E T="04">Federal Register</E> of December 19, 2023 (88 FR 87782). FDA considered comments received and revised the guidance as appropriate in response to the comments, including clarifying the recommendations in ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 15k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━