FDA’s New Device Review Policy Hits Some Speed Bumps

Law360, New York (March 22, 2013, 7:39 PM EDT) -- Medical device attorneys are raising concerns that the Food and Drug Administration is unevenly implementing a new policy intended to accelerate product reviews, saying the new approval process has so far been unpredictable and could actually lengthen the time it takes a product to hit the market.

At the end of 2012, the FDA officially adopted a "refuse-to-accept" policy for a type of application for premarketing review — the 510(k) — that applies to less risky products. Under the policy, the FDA has 15 days to make...
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