The FDA published « Refuse to Accept Policy for 510(k)s » in August 2015, a new guidance document for medical device manufacturers. It aims at helping manufacturers of class II MD (mainly), to properly prepare and submit their 510(k) submissions to get approval in the US.

What changes:

In August 2015, the Food and Drug Administration (FDA) published the guidance document « Refuse to Accept Policy for 510(k)s », relevant from the 1st of October 2015. It replaced three guidance published between 1993 and 2012 :

  • « Premarket Notification (510(k)) Refuse to Accept Policy » of the 30th of June 1993
  • « 510(k) Refuse to Accept Procedures (K94-1) blue book memo » of the 20th of May 1994.
  • « Refuse to Accept Policy for 510(k)”s » of the 31st of December 2012.

An analysis of all 510(k) submissions submitted to the FDA between January and June 2015, demonstrated that administrative criteria were not complete for more than half of the 510k submission.

The purpose of this guidance is to explain how the FDA intends to perform “acceptance reviews” of all traditional, abbreviated, and special 510(k) submissions in order to ensure that specific acceptance criteria are assemble, as well as completeness of the submission.

Consequences:

Several checklists are provided in this guidance to help medical devices manufacturers  understanding which elements are required by the FDA to conduct a substantive review of a 510(k) submission, and to ensure that all necessary documents and information have been included in their 510(k) submission.

A 510(k) submission, defined by 21 CFR Part 807 Section E, will undergo a 2-step process:

  1. The acceptance review: The FDA assesses the completeness of the submission. FDA staff defines if the submission can be accepted with a preliminaries questions, and whether it contains all the elements, as defined by the applicable checklist, the FDA  conducts a substantive review. The acceptance review should be completed within 15 days from the reception of the 510(k) notification.
  2. The substantive review: The FDA assesses the quality of the information provided in the Submission, in order to grant the substantial equivalence of the device.

During the acceptance review, if a submission does not contain all of the elements provided by the appropriate checklist, and if no explanations are provided in case of omissions, the submission will receive a “Refuse to Accept” (RTA) designation. Submitters will be notified electronically if their submission has not been accepted, and which items are missing.

The 510(k) submitters can answer by providing the missing information within 180 days. The acceptance review will be conducted again within 15 days from the reception of the new information.

Submitters will also be notified electronically when their submission is accepted and when will begin the substantive review phase. If the FDA does not complete the acceptance review within 15 days, the submitter will be notified and the submission will be automatically passed along for substantive review.

Caution:

Manufacturers can make a “pre-submission” before sending their final 510(k) submission. The guidance document “The Pre-Submission Program and Meetings with Food and Drug Administration Staff” released on the 18th of February 2014, provides information on this USA : Guidance on the Refuse to Accept Policy for 510(k)s.

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