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Inventor Thomas Fogarty’s Newfound Optimism About FDA

In an interview with “The Gray Sheet,” renowned inventor and entrepreneur Thomas Fogarty says he is encouraged, based on his recent experience with FDA, that regulatory trends slowing U.S. device innovation can be reversed.

The idea that risk aversion and opaqueness at FDA are weakening the U.S. medical device innovation model is a truism among large segments of industry. But renowned inventor, entrepreneur and frequent FDA critic Thomas Fogarty says his recent dealings with top CDRH leaders give him reason to hope that the agency is moving in the right direction.

“What you see with FDA now is a change in attitude,” Fogarty said in a recent interview with “The Gray...

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