FDA has finalized a highly anticipated guidance document on its 510(k) program, but one of the most controversial sections of the 2011 draft version of the guidance, on the “special 510(k)” program, is absent.
The agency elected not to include discussion of special 510(k)s, or the similar abbreviated 510(k) program, in its final guidance, “The 510(k) Program: Evaluating Substantial Equivalence in Premarket...
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