Article preview from "The Gray Sheet"- March 26, 2012
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.
Article preview from "The Gray Sheet"- March 26, 2012
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 Sheet.” “They do not now want to be a deterrent to innovation in the medical field, and are really trying to change that.”
That is a significant adjustment in perspective from an industry leader who has labeled FDA an obstruction to medical progress. The adjustment is informed by Fogarty’s experiences over the past six months working directly with CDRH officials to develop new pathways for innovative products.
In October, Fogarty was one of 20 entrepreneurs, scientists and business leaders who joined CDRH’s “entrepreneurs-in-residence” program to assist the center in developing its new “innovation pathway” pre-market program for breakthrough products.
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