Last month, FDA updated and issued a final guidance titled, “Refuse to Accept (RTA) Policy for 510(k)s”. Another related guidance on Acceptance and Filing Reviews for PMAs was also updated and finalised.  The updates address provisions in the Obama enacted 21st Century Cures Act which amended Section 503(g) of the Food, Drug and Cosmetic Act (FD&C Act) and applied certain drug provisions to device-led combinational products.

In addition to the new RTA policy, the 510(k) guidance includes three checklists – one each for traditional, abbreviated, and special 510(k)s – for use by FDA staff in determining whether to accept a 510(k) for substantive review.  The guidance indicates that the RTA review should be conducted and completed within 15 calendar days of receipt of a 510(k). If the FDA refuses to accept the filing, it will notify the submitter and send a copy of the completed checklist to help the submitter identify the deficiency. The submitter may submit the additional information identified in the checklist and the FDA will perform the acceptance screening again, also within 15 calendar days of receipt of the information. If the FDA refuses to accept the filing a second time, the submitter is again notified and given the new checklist. If the agency accepts the filing, the submitter is notified and the FDA will begin a substantive review of the 510(k). If the FDA does not respond within the 15 days, the 510(k) is deemed accepted and the agency will also notify the submitter and begin a substantive review.

So, not hearing from FDA within 15 days after submission is, in most cases, a good thing and may mean the substantive review is proceeding.  How to increase the chances of not having RTA rejections?  The CRO Group includes a filled out RTA checklist with every 510(k) we submit.  You can receive a complimentary copy of the guidance including the checklists here.  To speak with a CRO Group associate about your 510(K) and discuss the best way of answering the checklist questions, and moving past RTA review, click here.