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Join the FDA’s CDRH Real-World Evidence Public Meeting

The U.S. Food and Drug Administration (FDA) is announcing a virtual public meeting to share the Center for Devices and Radiological Health’s (CDRH) recent Real-World Evidence (RWE) program updates and activities.

As part of CDRH’s Medical Device User Fee Amendments 2022 (MDUFA V) commitments, the Center continues to develop real-world data (RWD) and RWE methods and policies to advance regulatory acceptance for premarket submissions, including expanded indications for use and new clearance/approval of new devices.

• Meeting Date: Thursday, January 30, 2025,11:00 a.m. – 12:00 p.m. ET
• Location: Webcast
• Registration Deadline: Tuesday, January 29, 2025, at 4:00 p.m. ET

Comments

Submit written comments under docket FDA-2024-N-5760 at www.regulations.gov by March 3, 2025, to ensure the FDA reviews and considers comments.  

Questions?

If you have questions about this public meeting, contact CDRHClinicalEvidence@fda.hhs.gov.