FDA's updated
guidance on its 510(k) “refuse to accept” (RTA) policy gives agency staff more liberty to decide what elements of a submission are necessary to begin substantive review and to...
More Leeway For Reviewers In Updated 510(k) 'Refuse-To-Accept' Policy
An updated 510(k) “refuse to accept” guidance document gives FDA staff more opportunity to work with sponsors to smooth out product submissions without repeatedly halting and restarting the review clock with RTA determinations.
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