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Would-Be FDA 'Maturity Model' Pilot Might Reward Firms With Delayed Inspections

This article was originally published in The Gray Sheet

Executive Summary

"Mature" device manufacturers could put off an FDA inspection for a few years if they independently verify that they have robust quality metrics in place under a potential pilot program, CDRH's new compliance head says. The pilot would be part of FDA's plan under its Case for Quality to use a maturity model to prioritize facility inspections.

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