martes, 14 de abril de 2026

Another QMSR Town Hall – What Changes and What Stays the Same in FDA’s Inspection Process By Adrienne R. Lenz, Principal Medical Device Regulation Expert —

https://www.thefdalawblog.com/2026/04/another-qmsr-town-hall-what-changes-and-what-stays-the-same-in-fdas-inspection-process/?utm_source=rss&utm_medium=rss&utm_campaign=another-qmsr-town-hall-what-changes-and-what-stays-the-same-in-fdas-inspection-process With the Quality Management System Regulation (QMSR) compliance date of February 2, 2026, FDA has been convening a series of town hall discussions to help industry with compliance. In our previous post we discussed FDA’s final town hall prior to the compliance date and the Agency’s emphasis on risk, design, and culture of quality. On April 1, FDA held another town hall that reviewed the updated Inspection of Medical Device Manufacturers Compliance Program Manual (CP-7382.850) (the CP), which we blogged about previously.

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