Administrative questions or questions about the submission process are not interactions within the Q-Sub Program, and therefore do not need a formal pre-submission.

On June 2, 2023, the FDA issued its most recent guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The Q-Sub Program is used by the FDA to track the requests for feedback and interactions between the FDA and medical device companies prior to submitting for FDA approval. The 2023 guidance provides updated resources and tools for medical device companies, or submitters, looking to request feedback from the FDA during the development process of potential or planned medical devices.

Content and Purpose of Pre-Submissions

Pursuant to the FDA, “a Pre-Sub is appropriate when FDA’s feedback on specific questions would help guide product development and/or submission preparation,” but it “is not intended to be a pre-review of an intended submission or a pre-review of data to be provided in a submission.” The expanded Appendix 2 to the 2023 guidance includes examples of recommended pre-submission questions and demonstrates the scope and specificity that the FDA expects in pre-submissions. For instance, the FDA advises that a submitter include how it “addressed, or plan[s] to address, relevant guidance documents, regulations, special controls, or other applicable sources for [the] device or submissions type.”

Administrative questions or questions about the submission process are not interactions within the Q-Sub Program, and therefore do not need a formal pre-submission. Rather, such questions may be handled via email or telephone call. If a submitter is unsure about whether a request should be made under the Q-Sub Program, they can reach out via OPEQSubmissionSupport@fda.hhs.gov.

Updates to Types of Q-Subs

The 2023 guidance also highlights key updates to the different types of pre-submissions that fall within the Q-Sub Program:

• Accessory Classification Requests. Accessory classification requests are not pre-submissions, but a pre-submission prior to a formal accessory classification request should “guide product development” or “request feedback about application preparation.” This expands upon earlier guidance that such pre-submissions are an opportunity to “discuss the appropriate classification of the accessory prior to submission,” and provides a broader purpose to pre-submission requests submitted in anticipation of an accessory classification request.
• Predetermined Change Control Plans. Pre-submissions for the purpose of obtaining feedback on predetermined change control plans (PCCPs) prior to inclusion in a premarket submission are encouraged “as it provides an opportunity to work proactively with the FDA in the development of the PCCP, which helps to streamline the premarket review.”
• Submission Issue Requests. Submission issue requests maintain the same procedures and expectations as the 2021 guidance, but the 2023 guidance adds that “a [submission issue request] may be used to discuss a planned approach or strategy for addressing issues identified in an FDA letter.”
• Requests for Feedback Regarding Medical Device Development Tool (MDDT). These tools are now tracked with a universal tracking number, rather than through informational meeting Q-Subs. Additionally, Q-Subs should be identified as an “MDDT” on the cover letter.
• Requests for Emergency Use Authorizations (EUAs) or Requests for Feedback About EUA Submissions and the EUA Process. The 2023 guidance specifies that “there is a separate pre-EUA process that should be utilized for discussions about EUAs” and that this process is distinct from the pre-submission process.

Pre-Submission Meetings   

Prior to the 2023 guidance, the time frame for scheduling a meeting for a pre-submission was 60-75 days, with written feedback provided within 70 days or 5 days prior to the scheduled meeting (whichever was sooner). Now, written feedback is still provided within 70 days or 5 days prior to the meeting, but the timeline for scheduling a meeting has been expanded to 70-75 days, reflecting a more accurate time frame for the FDA’s review of the submission. Meetings are expected to be one hour in length. While prior guidance allowed longer meetings if properly requested, new guidance directs submitters to consider limiting the scope of the submission “to allow a more focused discussion that may yield more useful feedback.” Now, meetings that need to be longer than one hour are considered “rare.”

Content of Pre-Submission Meeting Minutes

The 2023 guidance states that pre-submission meeting minutes should be more thorough than previously recommended. Previously, meeting minutes were suggested to include “additional feedback and clarifications” discussed in the meeting. Now, it is advised that meeting minutes include “all discussion that occurs during the meeting.” This update enhances the efficacy of interactions with the FDA by mitigating potential contradictory views on the items discussed.

Additional Notable Updates

Number of Submissions

To mitigate confusion and make the development process more efficient, submitters are advised to submit only one Q-Sub at a time for a given device. If planning to submit many Q-Subs for one device, the first submission should include an overview of expected Q-Sub supplements related to the same device.

Requests for Designation

The 2023 guidance explains the importance of proactively submitting a request for designation (RFD) or pre-RFD to the Office of Combination Products, saving the submitter time by ensuring that the Q-Sub is sent to the correct FDA center.

Method of Feedback

Where a Q-Sub includes an option for the method of feedback, the submitter “should clearly indicate… what type of feedback [they] are requesting.” Certain types of Q-Subs offer only written feedback, others offer written feedback followed by a meeting, and some offer either written feedback or a meeting. It is important that the method of feedback sought is clearly indicated so that feedback is provided and meetings are scheduled in a timely manner.

Expectations for Comments by the FDA on New Information

The 2023 guidance sets new expectations for FDA comments on new information provided between receiving written feedback and holding the meeting. Prior guidance stated that the FDA is “generally unable to comment” on such information; now “submitters should not expect FDA” to comment on new information during that time period.

Key Takeaways

The 2023 guidance tempers expectations for the length of feedback meetings, the scheduling timeline for those meetings and what feedback the FDA is able to provide. Additionally, the 2023 guidance clarifies that feedback regarding MDDTs and EUAs have processes separate from the Q-Sub Program. These updates, along with the guidance’s expanded rationale for certain procedures, are designed to garner more accurate and detailed submissions to serve the FDA’s goal for the Q-Sub Program: “improv[ing] the quality of subsequent submissions, shorten[ing] total review times, and facilitate[ing] the development process for new devices.

For More Information

If you have any questions about this Alert, please contact Patrick C. Gallagher, Ph.D., Frederick R. Ball, Brittany Pagnotta, any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are regularly in contact.

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