Town Hall | Virtual
Event Title
Town Hall – Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Final Guidance
February 18, 2026
- Date:
- February 18, 2026
- Time:
- 1:00 p.m. - 2:00 p.m. ET
Summary
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.
Background
The FDA is issuing this guidance to clarify how the 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 guidance includes expanded and updated recommendations to FDA staff and sponsors considering using RWE to support a regulatory submission for medical devices.
This guidance has a 60-day transition period to allow time for both the FDA and sponsors to perform activities to operationalize the recommendations discussed in the guidance. As such, beginning on February 17, 2026, the FDA generally anticipates that sponsors will be ready to include the newly recommended information outlined in the guidance in their submission. The FDA, however, intends to review any such information if submitted at any time.
This document supersedes the final guidance of the same name, issued August 31, 2017.
Event Details
Registration is not required.
Date: February 18, 2026
Time: 1:00 – 2:00 p.m. ET
Platform: Microsoft Town Hall
Event Materials
The presentation, printable slides, and transcript will be available on this webpage and at CDRH Learn under “How to Study and Market Your Device,” sub-section “Cross-Cutting Premarket Policy.”
If you have questions about this town hall, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.