What is a Pre-Sub / Q-Sub?
A Pre-Sub (a.k.a. Q-Sub)) is a formal, voluntary written request from a sponsor or applicant asking FDA for feedback on specific aspects of a planned medical device submission or development plan before the sponsor makes a formal regulatory submission (such as a 510(k), PMA, IDE, De Novo request, or other premarket submission).
The purpose of the Pre-Sub is to secure feedback from FDA regarding a proposed regulatory strategy and/or planned performance testing, including the bench, pre-clinical and/or clinical study design, for inclusion in a final regulatory submission. Following FDA review of the Pre-Sub and receipt of written feedback, a meeting (face-to-face or teleconference) may be held with the Agency’s review team to discuss the feedback and address any issues which require further clarification
How to Prepare a Pre-Sub/Q-Sub?
A Pre-Sub is an informal submission with flexibility regarding the actual contents, nevertheless, the submission should include the following key information:
1.A description of the medical device, its principle of operation and mechanism of action to a level of detail that would enable an FDA reviewer a full understanding of the product, its components and clinical indications for use.
2.A description of the proposed regulatory strategy and a justification of the proposed regulatory pathway, including potential predicate device, if applicable.
3.An outline of the proposed performance data, including the bench tests, pre-clinical, clinical testing, which will support an eventual regulatory submission. Comprehensive test or study protocols, along with test results may be provided, as appropriate.
The main FDA guidance document describing the Pre-Sub (Q-Sub) program and covering recommendations for preparing the Pre-sub and related interactions with FDA can be downloaded from the FDA’s website – Guidance PDF (FDA): The Pre-Submission Program and Meetings with FDA Staff (https://www.fda.gov/media/93744/download).
Helpful tips when submitting a Pre-Sub/Q-Sub:
- Provide a “List of Consolidated Questions” with specific, focused questions to which you want FDA’s feedback. The questions should be clear and concise rather than vague or open-ended. For example, instead of “Is our plan OK?”, ask: “Does FDA agree that our proposed cytotoxicity and sensitization test plan (per ISO 10993-##) is sufficient to address biocompatibility for the proposed material?” Limit substantial topics to about 3–4 core issues so reviewers can provide deeper, actionable feedback.
- Submit the Pre-Sub well ahead of planned testing or submission milestones. Typically allow several months before you need the feedback to inform your development plan.
- If you’re requesting a meeting (in person or teleconference), include at least three possible meeting dates in your cover letter.
How we can help?
- Stein – Regulatory Affairs Consulting has extensive experience in preparing and submitting Pre-Submissions (a.k.a. Q-Subs) and can assist in securing feedback from FDA regarding your proposed regulatory strategy and/or planned performance testing, including the bench, pre-clinical and/or clinical study design, for inclusion in a final regulatory submission.
