Town Hall – FDA’s Quality Management System Regulation (QMSR): Medical Device Risk-Based Inspections

The U.S. Food and Drug Administration (FDA) will host a town hall for industry and other interested parties to discuss the updated Inspection of Medical Device Manufacturers Compliance Program (CP) Manual (CP 7382.850), effective February 2, 2026. This CP includes the new inspection process, which aligns with the requirements of the Quality Management System Regulation (QMSR).

• Date: April 1, 2026
• Time: 1:00 – 2:00 p.m. ET
• Registration is not required.

Questions?

If you have questions that you wish to submit for possible discussion during the town hall, please email QMSR-Rule@fda.hhs.gov. All questions must be received by March 16, 2026, to be considered for the discussion.