Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Guidance for Industry and Food and Drug Administration Staff December 2025

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices?utm_medium=email&utm_source=govdelivery Town Hall – Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Final Guidance The U.S. Food and Drug Administration (FDA) will host a town hall for industry and other interested parties to discuss the Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Final Guidance, issued on December 18, 2025. This guidance includes expanded and updated recommendations to FDA staff and sponsors considering using real-world evidence to support a regulatory submission for medical devices. Dates: February 18, 2026 Time: 1:00 – 2:00 p.m. ET Registration is not required. Town Hall – Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Final Guidance February 18, 2026 https://www.fda.gov/medical-devices/medical-devices-news-and-events/town-hall-use-real-world-evidence-support-regulatory-decision-making-medical-devices-final-guidance?utm_medium=email&utm_source=govdelivery