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)
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
Refuse to Accept Policy for 510(k)s (OLD) – Until September 30, 2015
Document issued on: December 31, 2012
The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review.
This guidance document supersedes two existing guidance documents entitled 'Center for Devices and Radiological Health's Premarket Notification (510(k)) Refuse to Accept Policy' issued on June 30, 1993 and '510(k) Refuse to Accept Procedures, 510(k) Memorandum K94-1' issued on May 20, 1994.
Focusing FDA's review resources on complete submissions will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible. Moreover, with the enactment of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the Medical Device User Fee Amendments of 2007 (MDUFA II) and the Medical Device User Fee Amendments of 2012 (MDUFA III), FDA agreed to performance goals based on the timeliness of reviews. Acceptance review therefore takes on additional importance in both encouraging quality submissions from submitters of 510(k) notifications and allowing FDA to appropriately concentrate resources on complete submissions.
Therefore, we have modified our 510(k) Refuse to Accept (RTA) policy to include an early review against specific acceptance criteria and to inform the submitter within the first 15 calendar days after receipt of the submission if the submission is administratively complete, or if not, to identify the missing element(s). In order to enhance the consistency of our acceptance decisions and to help submitters better understand the types of information FDA needs to conduct a substantive review, this guidance, including the checklists included in the appendix, clarify the necessary elements and contents of a complete 510(k) submission. The process we outline is applicable to all devices reviewed through the 510(k) notification process and has been compiled into checklists for use by FDA review staff.
It is critical to distinguish between the completeness of the regulatory submission, and the quality of the data provided and any studies conducted in support of the submission. The assessment of the completeness of the 510(k) occurs during the acceptance review, while the assessment of the quality of the submitted information occurs during the substantive review.FDA will base acceptance on the objective criteria outlined in the associated Acceptance Checklist and not on the quality of the data.
FDA encourages all submitters to provide an electronic copy (eCopy) in place of one of the two hard copies of the 510(k) submission. FDA has issued guidance to implement Section 745A(b) of the FD&C Act, added by section 1136 of FDASIA, which provides statutory authority to require an eCopy for most submissions, including 510(k) submissions and amendments. With the implementation of this provision a valid eCopy will be required in order for a 510(k) to be processed and for the acceptance review to begin.
Download FD&C Act As Amended on 2013-04-24
Last Updated: 2015-08-04