Guidance Update: FDA revises Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

The FDA released a revised draft of the Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program on 15 March, 2024. When finalized, this guidance will supersede both the current version of the guidance document which has been in effect since 2 June, 2023, and the Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies issued on 19 February, 1998.

FDA’s Q-Submission (Q-subs) program is intended to allow manufacturers to engage and request feedback from the FDA as it relates to medical device submissions. The Q-Submission program includes Pre-Submissions (Pre-Subs), Submission Issue Requests (SIRs), Study Risk Determinations, Informational Meetings and PMA Day 100 Meetings.

The scope of the revised draft guidance document remains the same. The primary purposes for the updated guidance document are to incorporate the existing contents of the Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies and to provide clarity in identifying when an informal communication with FDA would generally be appropriate instead of a formal Pre-Sub request.

Some takeaways from the updated draft guidance:

• Timelines and format for Q-subs remain the same, with Q-sub submissions now accepted through eSTAR.
• Pre-sub meetings should be limited to one hour. The current version of the guidance document states that if a manufacturer believes that more than one hour is needed for a pre-sub meeting, a rationale may be provided with the proposed longer meeting duration. The updated draft guidance, however, recommends that the manufacturer consider limiting the scope and the questions of a pre-sub if more than one hour is needed.
• Pre-Subs should typically have no more than 7-10 questions, with these questions divided between no more than four substantial topics. In the updated draft guidance, FDA asserts that too many questions do not result in as productive discussions or feedback and therefore manufacturers should consider limiting the number of questions in a Pre-Sub and focusing first on high priority topics in order to obtain the most useful feedback from FDA.
• Feedback from one Pre-Sub question may impact the answer to another question, with FDA stating that they may not be able to provide productive feedback to questions which are dependent on each other. In these cases, manufacturers should consider limiting their questions to focus on topics which are highest priority and which will inform questions on other issues, in an initial Pre-Sub. After obtaining FDA feedback, the manufacturers can then submit additional topics in subsequent Pre-Sub(s).
• Requests for FDA feedback related to certain quality and compliance matters are considered to be within the scope of the Informational Meeting Q-sub mechanism. As an example, the draft guidance mentions that an Informational Meeting Q-sub could be used to seek feedback during product development or during early stages of establishing a Quality System. This update seems to encourage manufacturers to adopt a more proactive approach when it comes to their quality management system. The example from the new draft guidance replaces the example used In the current version of the guidance document, which concerned compliance actions such as obtaining FDA feedback regarding inspectional observations listed in FDA Form 483 to aid in the preparation of a response.
• Informal discussion and interaction with FDA are appropriate for questions that can be readily answered based on the FDA reviewer’s experience and knowledge without requiring additional background information from the manufacturer, in-depth review, or other FDA staff involvement. The draft guidance provides an example of what FDA considers to be an informal communication.
• FDA clarifies that the feedback they provide will be focused on the specific questions from the Pre-Sub. If FDA’s feedback does not mention a topic that is out of the scope of the Pre-Sub questions, additional information on that topic may still be needed in future submissions when the topic is subject to review. Namely, manufacturers should not expect FDA’s feedback during a Pre-Sub to be exhaustive for a particular topic as the feedback is intended to address the specific Pre-Sub questions.
• Minor updates to the appendices to reference some of the other newer guidance documents and to clarify language.

This draft guidance is open for comments until 14 May, 2024.