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Will ‘Maturity Model’ Pilot Mean Fewer US FDA Inspections for Medtech?

So-called 'mature' medical device companies could put off an inspection by the US FDA for a few years if they independently verify that they have robust metrics in place to gauge manufacturing and product quality, according to a pilot program that the agency hopes to set up by the end of 2017.

So-called 'mature' medical device companies could put off an inspection by the US FDA for a few years if they independently verify that they have robust metrics in place to gauge manufacturing and product quality, according to a pilot program that the agency hopes to set up by the end of 2017.

The proposed pilot, under which firms would have to share their findings with the agency, is part of FDA's plan under its Case for Quality initiative to use a...

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