federal_register: 2025-23252

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2025-23252 Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability Notice 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. 2025-12-18 2025 12 https://www.federalregister.gov/documents/2025/12/18/2025-23252/use-of-real-world-evidence-to-support-regulatory-decision-making-for-medical-devices-guidance-for https://www.govinfo.gov/content/pkg/FR-2025-12-18/pdf/2025-23252.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...

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