FDA Test Drives Its Draft Refuse to Accept Policy for 510(k) Notices

Following the August 2012 publication of its draft refuse to accept (RTA) policy for 510(k) premarket notifications (510(k) notice), and just after the closing of the comment period in October, the Food and Drug Administration (FDA or the agency) began informally implementing the draft policy. This informal implementation of the draft guidance has highlighted the need for additional clarity surrounding checklist items, as well as greater uniformity in reviewer interpretation and application of the checklists between the various branches and divisions within the Center for Devices and Radiological Health (“CDRH”).

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