Would-Be FDA 'Maturity Model' Pilot Might Reward Firms With Delayed Inspections
This article was originally published in The Gray Sheet
"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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