FDA Vows To Speed Up Some Medical Device Guidance

Law360, New York (September 5, 2013, 6:20 PM EDT) -- The U.S. Food and Drug Administration on Thursday promised to issue guidance more quickly when its expectations change regarding the content of approval applications from medical device manufacturers, acknowledging that it can often be years before it officially discloses the agency’s new approaches.

In a proposed “standard operating procedure,” the FDA said it would issue guidance that takes effect immediately if three criteria apply — new safety information arises concerning certain devices or testing, the information changes regulatory expectations and traditional guidance allowing upfront public feedback...
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