Guidance for Industry and Food and Drug Administration Staff
Document issued on: August 4, 2015
As of October 1, 2015, this document supersedes “Food and Drug Administration’s Refuse to Accept Policy for 510(k)s,” dated December 31, 2012, “Premarket Notification (510(k)) Refuse to Accept Policy,” dated June 30, 1993, and “510(k) Refuse to Accept Procedures (K94-1) blue book memo”, dated May 20, 1994.
Refuse to Accept Policy for 510(k)s (REVISED) – Effective As Of October 1, 2015
On August 4, 2015, FDA’s Center for Devices and Radiological Health (CDRH) issued a revised version of the guidance document “Refuse to Accept Policy for 510(k)s” that will go into effect on October 1, 2015. This guidance will replace the prior version of this guidance issued on December 31, 2012.
The purpose of the “Refuse to Accept Policy for 510(k)s” guidance is to describe the 510(k) Refuse to Accept (RTA) process that encourages submission of administratively complete submissions and the information FDA believes is necessary to conduct a substantive review and to reach a determination regarding substantial equivalence.
Since implementation, clarification and improvements to the RTA process have been identified through review of the RTA program, and comments received from FDA review staff and industry. The RTA guidance and checklist revisions are intended to further reduce the number of submissions that are considered administratively incomplete upon initial receipt.
Below is a summary of the types of changes incorporated into the revised guidance document and checklists:
- Clarify text to reflect checklist and RTA process modifications
- Removal of language that had the potential to lead to substantive review
- Update to references, guidance, and links changed since the prior checklist version
Streamline checklists to reflect practical review practice:
- Removal of criteria non-critical to initiate review (e.g., 510(k) Summary and 510(k) Statement contents, Standards Data Report Forms )
- Addition of options to permit reviewer discretion to accept files lacking certain non-critical information (e.g., software section permits discretion on applicability of content)
- Separation of elements better reviewed independently (e.g., electrical safety and EMC)
- Modifications to reflect changes in review policy (e.g., sterility section modified to reflect new reprocessing guidance)
Modification of checklist elements to improve clarity:
- Clarify text throughout checklist to improve understanding of information needed to address elements (e.g., information on prior submissions)
- Clarify text to remove language/elements that had the potential to lead to substantive review (e.g., removal of assessment of 510(k) Summary contents)
- Combine elements asking for similar information (e.g., substantial equivalence determination)
- Clarify/update elements per comments from FDA review staff and industry (e.g., addition of “N/A” boxes in Preliminary Questions section)
- Update to references, guidance, links changed since the prior checklist version
Improve Usability for Industry:
- Include page number column in checklist for industry to identify location of elements in submission
The RTA guidance and checklist revisions do not represent significant changes to the prior version of the guidance, but rather are targeted to assist FDA review staff and industry by clarifying the types of information FDA believes are necessary to make a submission administratively complete.
FDA also encourages submitters complete and submit acceptance checklists with their submissions that identify the location of supporting information for each RTA element.
Download Refuse to Accept (RTA) Policy Guidance (REVISED) on August 4, 2015 – Effective As of October 1, 2015
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Last Updated: 2015-08-04
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