Blog Post

QMSR: Welcomed by the Industry, but Lacking in Practicality

01 Apr 2022

On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting, where the Committee discussed the proposed rule titled "Medical Devices: Quality System Regulation Amendments." If finalized, the proposed rule will rename the current 21 CFR Part 820 as the Quality Management System Regulation (QMSR). In our previous post, we noted both the industry representatives and the Committee welcomed the proposed rule but agreed that it may have an overly ambitious implementation timeline, especially in light of the ambiguity in some key areas, such as inspection. These concerns were echoed by FDA, which acknowledged the need to engage in a variety of implementation activities including personnel training, inspection approach finalization, and revising relevant regulations and other documents impacted by the rule. 

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