On August 4, 2015, the US Food and Drug Administration (FDA) released an amended guidance for its Refuse to Accept (RTA) Policy for accepting 510(k) submissions. The amended RTA policy takes effect on October 1, 2015 and supersedes three previous documents, the FDA’s “Refuse to Accept Policy for 510(k)s,” dated December 31, 2012, “Premarket Notification (510(k)) Refuse to Accept Policy,” dated June 30, 1993, and “510(k) Refuse to Accept Procedures (K94-1) blue book memo”, dated May 20, 1994.
The revised policy more clearly delineates the necessary elements and contents of a complete 510(k) submission and is primarily intended to make it easier for 510(k) applicants to comply with the policy by providing submissions that are “administratively complete”. While the previous 2012 RTA policy appeared to be a more rigorous, substantive review of the 510(k) content and quality, the revised policy focuses solely on determining the completeness of the submission rather than a substantive review of its content.
The revised checklist states the following under the device description section “Submission contains representative engineering drawing(s), schematics, illustrations, photos and/or figures of the device.” whereas the previous checklist states “Submission contains representative engineering drawing(s), schematics, illustrations and/or figures of the device that are clear, legible, labeled, and include dimensions.” From this example, it can be seen that the emphasis of the revised policy is to confirm the presence and completeness of required information as opposed to reviewing the quality and accuracy of the information.
In addition, the revisions include streamlining and modification of acceptance checklist criteria to better align with current 510(k) review practices and related guidance documents. Many of the changes in the checklist allow applicants to provide alternative information in certain areas for demonstrating completeness of the submission. Criteria for information not critical to initiate submission review were removed from the checklists. Lastly, checklists now include a page number column to identify the location of certain elements making it easier for FDA reviewers to find information and more efficiently reach a completeness determination. While many companies were already handwriting a column into the form, the FDA saw this habit as best practice and adopted in the new guidance. By employing simple administrative and organizational principles, these additions will improve the usability and effectiveness of the checklists for both industry and FDA.
Based on industry experience, many RTA deficiency letters were issued due to inability to locate information within the submission, because alternative information was not officially recognized as a measure to demonstrate completeness or because the FDA reviewer conducted a substantive review of the submission content rather than a review of completeness. Therefore, the recent RTA policy updates will be helpful in reducing the number of submissions that are considered by FDA to be administratively incomplete which will lead to fewer delays in US commercialization plans of 510(k) applicants. Considering these revisions, the following are expected to be the big “wins” for industry:
“Wins” for industry
- More specific and accurate delineation of RTA scope
- Improved clarity, use and effectiveness of checklists
- Streamlined process, guidance and checklists to align with practical review process
Although the RTA guidance updates do not represent significant changes to the 2012 version, several details of the checklists have changed and applicants should pay careful attention to the revised RTA policy requirements to avoid delays during the RTA review of their 510k submissions to maximize these process improvements.