New Q-Submission Guidance: Key Insights and Tips

The U.S. Food and Drug Administration (FDA) recently issued an updated draft guidance on the Q-Submission Program for medical device submissions, introducing several key changes.

This alert provides an overview of the FDA's draft guidance, including examples of appropriate and inappropriate Q-Submission questions, limitations on the number of topics and questions, and tips to help you facilitate an effective and productive Q-Submission.

Key Aspects of the FDA’s Draft Q-Submission Program Guidance

The FDA’s draft guidance proposes several notable changes to its existing guidance on the Q-Submission Program. The primary focus is on limiting the scope of the agency’s pre-submission practice, likely due to a significant increase in the number of pre-submissions in recent years.

Informal Interactions

The draft guidance proposes that questions that “can be readily answered based on [an] FDA reviewer’s experience or knowledge that do not require additional background information, an in-depth review, or other FDA staff involvement” would no longer fall within the Q-Submission Program. Instead, the draft guidance suggests that these questions would be appropriate for informal interactions “and may be handled via email or telephone call.” FDA recommends contacting the appropriate review division or FDA’s Office of Product Evaluation and Quality (OPEQ) Submission Support to discuss the appropriate pathway for your request. Additionally, we have found the FDA’s Division of Industry and Consumer Education (DICE) to be a valuable resource for these types of questions.

Inquires Outside the Q-Submission Program

Under the FDA’s draft guidance, other inquiries that would fall outside of the Q-Submission Program would include (but not be limited to):

• Administrative questions (including questions about submission processes and deadlines);
• Interactive review of issues identified while a marketing submission is under active FDA review; and,
• Requests for clarification on device-specific guidance documents or voluntary consensus standards unrelated to a specific device.

The FDA’s draft guidance also provides examples of interactions that would fall outside the Q-Submission program but would require some other form of formal (as opposed to informal) submission. These would include requests for Emergency Use Authorizations, requests for designation (RFDs), and pre-RFDs, among others.

Limitations on Topics and Questions

If finalized, the FDA’s draft guidance would limit the number of topics and questions sponsors can submit through the Q-Submission Program. The draft guidance proposes limiting pre-submissions to three or four topics (which is consistent with the FDA’s current final guidance), but it would also limit the total number of questions to between seven and ten across each of the topics submitted. If a submission includes an excessive number of topics, the guidance indicates that the FDA may contact the submitter to prioritize the topics. The FDA may suggest addressing the lower priority topics in subsequent Pre-Subs. We recommend prioritizing your questions and incorporating multiple Q-Submissions into project timelines if you have numerous topics.

Premarket Approval (PMA) Day 100 Meetings

The draft guidance also addresses Premarket Approval (PMA) Day 100 meetings. While the guidance provides that Day 100 meetings would still be used to discuss major deficiencies during the PMA process, it also proposes that applicants file a Submission Issue Request (SIR) to enable further discussion of major deficiencies. The timelines here are not entirely clear, and if the FDA adopts a final version of its draft guidance, a key question for companies facing regulatory issues during the PMA process will be whether (and to what extent) it addresses these ambiguities.

Contact Us

Gardner Law can assist with drafting and strategy for your Q-Submission, prepare you for the meeting, and attend the FDA call to facilitate a productive discussion and help achieve your objectives. Contact us if you have any questions.