FDA Asks for Comments on Draft Guidance for Premarket Notification Admin Procedures
The Food and Drug Administration is asking for comments on a draft guidance entitled “Refuse to Accept Policy for 510(k)s,” which explains the procedures and criteria FDA intends to use in determining whether a premarket notification (510(k)) submission is administratively complete and should be accepted for substantive review. FDA’s draft guidance is not in effect, but once it’s final it will be applicable to 510(k)s reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). Comments should be submitted by Sept. 27 to ensure consideration before the final version of this guidance is published.
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FDA said it modified the 1993 and 1994 guidances on the “refuse to accept” policy. For example, FDA’s proposed new policy would include an early review against specific acceptance criteria, in which FDA would inform the submitter within the first 15 calendar days of receipt of the submission if the submission is administratively complete, or if not, to identify the missing element(s). The draft guidance also clarifies the necessary elements and contents of a complete 510(k) submission. These elements are applicable to all devices reviewed through the 510(k) notification process in CDRH and CBER and have been compiled into checklists for use by FDA review staff, FDA said.
FDA's draft guidance is available here.