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A Long, Strange Trip: 510(k) Reform At One Year

A rundown by “The Gray Sheet” of the most significant 510(k) reform actions taken in 2011, what’s on deck for 2012 and what reform will mean to device makers in the near term.

A year into FDA’s comprehensive 510(k) reform plan, at least one thing is apparent: FDA is setting a new personal best, releasing scores of new guidance documents, standard operating procedures, pilot programs and other initiatives at a breakneck pace.

But what it will all mean for the long-term functioning of the heavily used device review path remains to be...

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