← FDA GUIDANCE
FDA GUIDANCE · FINALDecember 18, 2025
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff
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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.
Status
Final
Topic
Postmarket, Premarket, Real World Data / Real World Evidence (RWD/RWE)
Issue date
December 18, 2025
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