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

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.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.