On September 6, 2018, FDA launched the Quality in 510(k) Review Program Pilot (“Quik”). With the name “Quik,” it has a lot to live up to. The goal of the program is to simplify the 510(k) process by providing an alternate method of preparing a 510(k) using FDA’s eSubmitter software to format the submission. The new process is being piloted for a select list of device types. Eligible devices must also be reviewed by CDRH, not be classified as combination products and constructed with the eSubmitter template “non-In Vitro Diagnostic Device – 510(k).” The agency considers the eligible devices selected to be moderate risk and well-understood.
According to the user manual, the eSubmitter tool is “is intended to automate the current paper submission process, allowing for quicker completion once users are accustomed to the software, as well as speed up the filing process with FDA.” It can be set up locally or on a network, to allow multiple users to access a submission in process. Most of the documentation currently submitted in a 510(k) will be uploaded as attachments. However, some of the information will need to be entered into fields within the software. There may be challenges if content requires review from individuals outside of the network or if it is installed as a single user application. From a practical perspective one can envision needing to maintain parallel working documents to exchange and review content prior to entering it into the application. This may actually add time to the 510(k) construction process. Once all information is entered, the eSubmitter packages the 510(k) in a file that is physically delivered to CDRH’s Document Control Center. A paper copy will no longer be required.
Submissions eligible for the program will be reviewed according to a faster timeline than a standard Traditional 510(k) submission. First, the Refuse to Accept review that typically occurs in the first 15 days of 510(k) review will not be conducted. (However, FDA will review the submission to confirm eligibility and will convert the submission to the standard procedure and timeline if the 510(k) is found to be ineligible.) During the review, the submission will not be placed on hold. All FDA requests for additional information will be made interactively with an expectation that the sponsor responds quickly. The final decision is intended to be made within 60 days.
While requests for clarification of the device design or its testing can typically be made quickly, many 510(k) requests for additional information ask for additional testing when FDA feels that methods and/or data provided in the submission were insufficient. Sponsors may find it challenging to respond to such deficiencies quickly to allow a total review timeline of 60 days. It will be interesting to see if the pilot program results in more sponsors needing to submit a second 510(k) if the first cannot be cleared within the timeframe. In a current Traditional 510(k) review, FDA requests additional information around day 60 of their review and takes the remaining 30 days to review the additional information when submitted. If sponsors find that multiple 510(k)s are required, the timelines will be increased as instead of a 30 day review after they complete the additional work, it will now be a new 60 day review. Also, a second user fee will be necessary.
For straightforward submissions that require only clarification or other updates that can be made quickly to address FDA requests, this program is likely to reduce overall review time. However, given many additional information requests take longer to respond to properly, the ability of a “Quik” 510(k) to reduce review times more broadly is unknown. We will follow this pilot program and provide updates on its outcomes as they become available.