Refuse to Accept Policy for 510ks

Guidance for Industry and Food and Drug Administration Staff

FDA Revises Refuse to Accept (RTA) Policy Guidance for 510(k)s

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.

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:

Guidance Document

  • 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

Checklists

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

[download id=”20048″]

Refuse to Accept Policy for 510(k)s

Issued on December 31, 2012

Scope

The information presented in this document is intended to provide FDA staff with a clear, consistent approach for acceptance review for traditional, special, and abbreviated 510(k) notifications and to outline the RTA policy on 510(k)s.

The acceptance policy does not alter the substantial equivalence decision-making process once the submission has been accepted for review; however, it does alter the start of the FDA review clock for purposes of MDUFA performance goals for those submissions that are not accepted for review.

For those submissions accepted during the initial acceptance review (i.e., within the first 15 calendar days of receipt of the submission), the FDA review clock start date is the date of receipt.

This document does not address the monetary aspects or the MDUFA goals associated with 510(k)s. Information pertaining to the fees and payment procedures for submission of a 510(k) notification can be found online; see “Premarket Notification [510(k)] Review Fees” (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134566.htm).

Conversion of Special 510(k) to Traditional 510(k)

FDA has developed separate checklists to address the differences in content for special and traditional 510(k) submissions. FDA staff will utilize the appropriate checklist based on the file type as designated by the submitter. In the event that the submitter has submitted a special 510(k), but FDA determines that the file should be converted to a traditional 510(k), FDA will  notify the contact person designated in the 510(k) submission of the conversion and the rationale for the conversion.

If the file is converted from a special to a traditional within the 15 calendar day acceptance review period, the Traditional 510(k) Acceptance Checklist will be used to conduct the acceptance review and the review clock start date will be assigned as outlined in the 510(k) Refuse to Accept Policies and Procedures section above. Given the differences in content requirements for special and traditional 510(k)s, it is likely that the converted submission will result in an RTA designation using the Traditional Acceptance Checklist. FDA staff should provide the completed Acceptance Checklist for traditional submissions indicating which elements are missing. The submitter may respond by providing the identified information and the subsequent acceptance review will proceed with the traditional checklist.

If the file is converted from a special to a traditional after the 15 calendar day acceptance review period, any missing information that would have resulted in RTA designation should be obtained during the substantive review.

If a 510(k) designated as a special 510(k) qualifies as a special 510(k), but the submission includes performance data, FDA should convert the submission to a traditional 510(k) and apply the traditional 510(k) checklist for acceptance review. Note that if performance data are provided and conducted under design validation (21 CFR 820.30(g)), for example, to demonstrate continued conformance with a special control or recognized standard, then a Special 510(k) may be appropriate.

Download FDA guidance in PDF

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Last Updated: 2015-07-17