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
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