The FDA recently issued a draft guidance titled, “Refused to Accept Policy for 510(k)s.” In addition to explanation of the new policy, the draft guidance includes three checklists – one each for traditional, abbreviated, and special 510(k)s – for use by FDA staff in determining whether to accept a 510(k) for filing. The draft guidance explains that two prior guidance documents, which this one will eventually replace, and its current checklist “deal[t] largely with administrative elements but [did] not address specific content that is essential for 510(k) review.” FDA hopes that that the new guidance and checklists “will clarify the content needed in traditional, special, and abbreviated 510(k) submissions to allow FDA to conduct a substantive review, thereby enhancing the quality of received 510(k) submissions and improving overall review time.”

Further, the draft guidance states that the acceptance review should be conducted and completed within 15 calendar days of FDA’s receipt of a 510(k). If FDA refuses to accept the filing, it will notify the submitter and send the submitter 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 FDA will perform the acceptance screening again, also within 15 calendar days of receipt of the information. If FDA refuses to accept the filing a second time, the submitter is again notified and given the new checklist. If FDA accepts the filing, the submitter is notified and FDA will begin a substantive review of the 510(k). If FDA does not respond within the 15 days, the 510(k) is deemed accepted and FDA will also notify the submitter and begin a substantive review.

The checklists include five preliminary questions to be answered before the content of the 510(k) is compared to the acceptance criteria: Is the product a device or a combination product with a device component? Is the application with the appropriate Center (CDRH or CBER)? Is 510(k) the appropriate regulatory submission? Is there a pending PMA (pre-market approval application) for the same device and indications for use? And, if clinical studies have been submitted, is the submitter the subject of the Application Integrity Policy?

In theory, the draft Guidance should help the FDA focus its resources on substantive review of complete 510(k) notifications and reward submitters who follow the regulations and guidance documents to make a complete submission. There are some potential issues, however, that may affect FDA’s ability to achieve its goals and also potentially frustrate submitters. For example, Question 11 of the checklist for a Traditional 510(k) asks if there is an applicable device specific-guidance or special control, has documentation been provided to establish that the submitter has followed the recommendations? There are many device-specific guidance documents and special controls, and this places a burden on the reviewer to be aware of them. If the reviewer is not aware of an applicable device-specific guidance, the 510(k) may be accepted only to be rejected after time has been spent on the substantive review and the deficiency has come to light. Also, if FDA refuses to accept the 510(k) and simply checks this box, the submitter may not have much insight into the deficiency. Is there a device-specific guidance? Special Controls? What part of the device-specific guidance or special control was not addressed?

Another interesting issue could be how many rounds of a refusal to accept accompanied by a completed checklist, followed by the submission of additional information, the FDA will allow for one 510(k) notification and filing fee.