There has been much controversy about the new RTA FDA Guidance document titled "Refuse to Accept Policy for 510(k)s". The draft of this guidance was issued for review in August of 2012 and was recently released at the end of that year. However companies are still talking about the changes to the policy and the issues they have with them. As always, the draft guidance document went through the review process where companies could read through the document and provide comments. 

This guidance document is intended to review 510(k) submissions and provide feedback to the submitter within fifteen days after the submission was received. The submissions are reviewed for administrative purposes only, actual quality of data and detail is not reviewed. This is in hopes of saving the FDA and the submitter time by catching administratively incorrect submissions earlier in the process, therefore giving the FDA reviewers more time to focus on submissions that have been put together correctly. The submitter is able to correct any errors and resubmit without having to pay the user fee again.

In order to make this process more clear, the FDA has provided Refuse to Accept (RTA) checklists that are associated with traditional, abbreviated and specials 510(k)s. However companies have had issues with these checklists because they appear to "entail subjective judgments by review staff" rather than being completely objective.

So what does this mean for medical device companies submitting for 510(k) approval? Simply to follow the checklist and get the forms/administrative work correct. It could also mean a longer review period because the guidance was not completely clear on when the review period officially started. If an RTA is issued to a company, the review period will not begin until all administrative issues associated with the RTA are corrected, thus at a minimum adding at least 15 days to the review process. I am interested in seeing how this guidance is received in all companies.

--Jillian F. Walker

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