Rx-360 summary of FDA Final Guidance Refuse to Accept Policy for 510(k)s

Rx-360 has releases a summary of FDA Final Guidance Refuse to Accept Policy for 510(k)s.

FDA has published a revised final guidance document entitled "Refuse to Accept Policy for 510(k)s," which will go into effect on 1 October 2015. This guidance will replace the prior version of the guidance issued on 31 December 2012. The purpose of the guidance is to describe FDA's initial screening process for 510(k) submissions, which is used to determine if the submission is sufficiently complete to undergo substantive review. The guidance has been updated to incorporate internal FDA and stakeholder feedback on the implementation of the "Refuse to Accept" (RTA) process.

Key revisions include

(i) streamlining of checklists to reflect actual review practice, additional flexibility to permit reviewer discretion to accept files lacking certain non-critical information 

(ii) incorporation of guidance issued since the release of the prior version (e.g., recently issued device reprocessing guidance)

(iii) addition of a page number column for industry to identify the location of required elements in the submission

(iv) revisions to checklist items that could lead to substantive review during the screening process (i.e., to ensure only administrative review occurs during the screening process).

In addition, this version makes clear that FDA encourages submitters to complete and submit the relevant acceptance checklist with their submission to identify the location of supporting information for each RTA element.

This guidance document supersedes three existing guidance documents titled "Refuse to Accept Policy for 510(k)s" issued on 31 December 2012; "Center for Devices and Radiological Health's Premarket Notification (510(k)) Refuse to Accept Policy" issued on 30 June 30 1993; and "510(k) Memorandum K94-1" issued on 20 May 1994.

To view or download the FDA Guidance, click here