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Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Actions on Premarket Notification (510(k)) Submi

Posted Oct 16 2012 12:00am
The Medical Device User Fee Amendments of 2012 (MDUFA III), amended the Federal Food, Drug, and Cosmetic Act (the act) to authorize FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2012, including...
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