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Inventor Thomas Fogarty’s Newfound Optimism About FDA

This article was originally published in The Gray Sheet

Executive Summary

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.

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Protecting Device Innovation: An Interview With Tom Fogarty

Noted physician-entrepreneur Tom Fogarty has long been known for inventing breakthrough products. Here he discusses his recent efforts to protect the medical device innovation model, and corrects what he sees as serious flaws in its long-term viability, especially in the U.S.

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Device center staffers met to discuss several pending applications and the factors that should weigh heaviest in their review.

Risk And Benefit, Quantified: CDRH Expands Use Of New Statistical Framework

Decision analysis tools will be put into practice as part of the device center’s priority “innovation pathway” for breakthrough devices and in a pilot program focused on obesity devices. The techniques may allow for shorter development and review cycles, among other benefits, CDRH says.

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