On August 4, 2015, the FDA announced the availability of a guidance outlining the Agency’s updated Refuse to Accept policy for 510(k)s, that is scheduled to take effect starting October 1, 2015. This guidance will replace the current Refuse to Accept Policy for 510(k)s guidance, which was released in 2012, as well as the two guidances prior to that (the 1994 510(k) Refuse to Accept Procedures blue book memo & the 1993 Premarket Notification (510(k)) Refuse to Accept Policy).
The reason behind the Agency’s modifications to their approval criteria is 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 appendices, clarify the necessary elements and contents of a complete 510(k) submission.”
Based on the guidance document (that can be found here), the FDA’s Refuse to Accept (RTA) Principles include the following:
The document also states that FDA staff will answer the preliminary questions within 15 calendar days of receipt of the 510(k). The Agency anticipates these questions will be answered as an initial screening of the submission by the lead reviewer. The preliminary questions are:
Overall, a majority of the changes in the new guidance were made to various checklists and information included in the appendices, which help companies make sure they are submitting a complete application. For all of the details and to view the full guidance, click here.
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