FDA Sheds Light On Medical Device Risk Reviews

Law360, New York (March 27, 2012, 7:58 PM EDT) -- The U.S. Food and Drug Administration issued its first-ever guidance Tuesday on how it analyzes the risks of medical devices before they hit the market, revealing the agency would recognize that patients with life-threatening illnesses might tolerate riskier devices than other patients.

The FDA issued the final guidance for both the industry and its reviewers roughly six months after a draft version, in a relatively quick move that could streamline the premarket review process amid a push from the device industry to speed up the process....
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