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Federal Register: Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availabilit

Posted Jan 02 2013 12:00am
The FDA is announcing the availability of the guidance entitled "Refuse to Accept Policy for 510(k)s.' The purpose of this document is to explain the procedures and criteria FDA intends to use in determining whether a 510(k) submission is administrative
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