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GUIDANCE DOCUMENT

Draft: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff December 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2023-D-4395
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

FDA is issuing this draft guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be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 This draft guidance also proposes expanded recommendations to the 2017 guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. The 2017 final guidance remains in effect until this draft guidance is finalized.
 

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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-4395.

 
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