FDA Issues Guidelines For Back-And-Forth In Device Reviews

Law360, New York (March 5, 2013, 7:27 PM EST) -- The U.S. Food and Drug Administration on Tuesday released new guidelines on how the agency should communicate with medical device makers during the review process, part of last year's user fee agreement aimed at speeding up device reviews, in part by increasing communication.

The medical device user fee agreement, which nearly doubled user fees for the industry to $595 million over five years, includes several goals for the FDA to get device reviews completed more quickly and more predictably.

Among other things, the FDA committed to...
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