The US Food and Drug Administration (FDA) has published two updated guidance documents on how it accepts, reviews and may refuse to accept 510(k) and pre-market approval (PMA) submissions. The two guidelines include only minor revisions, acording to the Agency, they were apparently reissued to reflect new requirements for clinical studies and certain other updates.
The guidance documents are titled ‘Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)‘, and ‘Refuse to Accept Policy for 510(k)s‘.
The PMA guidance reiterates why FDA may refuse to file a PMA submission, including:
The 510(k) guidance details an early FDA review against specific acceptance criteria, with the submitter being advised within the 15 calendar days if the submission is “administratively complete”, and so can move to a “substantive review” or if not, to identify the missing element(s). To help provide consistent acceptance decisions, and to help submitters better understand any information gaps, the guidance includes checklists that identify the necessary elements and contents of a complete 510(k) submission. Three checklists are included in the guidance, vovering Traditional, Abbreviated and Special 510(k) types.