Town Hall | Virtual
Event Title
Town Hall – FDA’s Quality Management System Regulation (QMSR): Medical Device Risk-Based Inspections
April 1, 2026
- Date:
- April 1, 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 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).
Background
On February 2, 2026, the FDA stopped using the Quality System Inspection Technique (QSIT) for device inspections and began utilizing the inspection process described in the updated Inspection of Medical Device Manufacturers Compliance Program (CP) Manual (CP 7382.850). After February 2, 2026, the FDA is no longer using the following documents: Inspection of Medical Device Manufacturers (7382.845) and Medical Device PMA Preapproval and PMA Postmarket Inspections (7383.001).
Event Details
Registration is not required.
Date: April 1, 2026
Time: 1:00 – 2:00 p.m. ET
Platform: Microsoft Town Hall
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.
Event Materials
The presentation, printable slides, and transcript will be available on this webpage and at CDRH Learn under “Postmarket Activities,” sub-section “Quality Management System Regulation (QMSR).”
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.