FDA Releases Medical Device User Fees For 2013

Law360, New York (July 30, 2012, 7:32 PM EDT) -- The U.S. Food and Drug Administration on Monday announced next year's user fees for medical device applications, the first set of fees to be announced since President Obama signed the user fee reauthorization into law three weeks ago.

Standard premarket applications for devices will set sponsors back $248,000 during the 2013 fiscal year, which begins Oct. 1 of this year, up from $220,050 for a PMA last year. A 510(k) premarket notification, a far less stringent — and more popular — way to get devices on...
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