Minor Updates to FDA Pre-Submission Guidance With More to Come

June 21, 2023By Véronique Li, Senior Medical Device Regulation Expert & Allyson B. Mullen

On June 2, 2023, FDA issued the latest version of its guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry.  For example, FDA expressly notes that feedback on EUAs is outside the pre-submission process, and pre-submission meetings include videoconferences.  We discuss several of the notable points in this post.

Timing Considerations

Traditionally, pre-submission meetings have occurred 60 – 75 days from FDA receipt of submission. Now FDA says that “[m]eeting dates between 70 – 75 … days are most likely to be feasible.” While the new time frame is within the old timeframe, it is a shift to the later side of the range and should be considered for planning purposes. The language also includes a greater level of uncertainty as compared to the previous 60 – 75-day estimate, and submitters should be aware that FDA may not always be able to meet its 70 – 75-day estimate. While this is not new, the language in the guidance may allow for this to occur more frequently. Sponsors will, however, have transparency as to the timing, thanks to FDA’s updates to the CCP, as discussed in our prior post (here).

Administrative Content

Beyond the table in the guidance document that summarizes Q-Sub types, method of feedback offered by each, and timeframe of written feedback or holding a meeting, FDA has taken the extra step to highlight that a submitter “should clearly indicate what type of feedback” is being requested. FDA has warned that failure to do so could result in feedback and meetings not being provided in a timely manner. This is a minor, but important, element and is a new consideration under administrative content for those Q-Subs with an option for the method of feedback (here). In fact, this element is incorporated in the new pre-sub eSTAR, which FDA recently announced (here).

Predetermined Change Control Plans

As our readers will know, FDA recently issued a draft guidance related to Predetermined Change Control Plans (PCCPs) (see our prior post here). In the revised Pre-Submission Guidance, FDA “highly recommends” submitting a pre-submission to obtain feedback on a PCCP, if a sponsor is considering including one in a future pre-market submission. As discussed in our prior post, PCCPs allow for modifications, within the bounds of the PCCP, following FDA authorization of the PCCP. An approved or cleared PCCP describes planned changes that may be made to the device that otherwise would have required a supplemental submission. FDA makes it a point to now encourage the pre-submission as a mechanism to work with FDA in the development of a PCCP and as a way to streamline premarket review. As noted in the PCCP guidance, however, PCCPs are not authorized through a pre-submission.  Such authorization is only done through a premarket submission, such as a 510(k) or de novo.

Draft Guidance

Finally, as part of MDUFA V, FDA has committed to issuing an updated draft of this Q-Sub guidance, by March 31, 2024. The new, draft guidance will include information to assist applicants and review staff in identifying circumstances in which informal communication is more appropriate than a pre-sub for an applicant’s question. In doing so, we hope FDA will adopt an open mind when it comes to expanding the topics on which it will consider providing informal feedback. We see this as being a “less burdensome” approach and a way to strengthen FDA’s vision of providing patients and providers with timely access to medical devices by providing real-time feedback.

Like other guidance documents that preceded it, the draft guidance will be open to the public for comment. Once the draft guidance document has been closed to public comment, FDA intends to issue a final guidance within 18 months. Once final, the guidance will be implemented and review staff will be trained.

Categories: Medical Devices