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

"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.

So-called "mature" medical device companies could put off an FDA inspection for a few years if they independently verify that they have robust metrics in place to gauge manufacturing and product quality, CDRH's new compliance chief

says. The catch? The firms have to share their findings with the agency.

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