At FDA, a New Goal, Then a Push for Speedy Device Reviews

November 30, 2018

(Associated Press) – And yet the next year, Shuren and his team adopted an approach that surprised even some of his closest colleagues: The FDA would strive to be “first in the world” to approve devices it considered important to public health. The agency’s shift mirrored the talking points of the $400 billion medical device industry — a lobbying behemoth on Capitol Hill — and ushered in a series of changes that critics say have allowed manufacturers to seek regulatory approval for high-risk devices using smaller, shorter, less rigorous studies that provide less certainty of safety and effectiveness.

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