Regulatory pathway · all topics

Pre-Submission (Q-Sub)

A Pre-Submission, also called Q-Sub, is a free voluntary mechanism to request feedback from FDA before a formal submission. Filed under the Q-Submission Program guidance (Sept 2023). Typical written response within 70 days, in-person or teleconference meeting within 75-90 days. Best used to align on study design, predicate strategy, and questions where regulatory uncertainty is high. Pre-Sub feedback is not binding but typically reflected in final review.

Source

FDA, 'Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program' (Sept 2023)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program

How MedTek OS handles this

Compass drafts the pre-submission (q-sub) workflow with confidence-gated content.

The platform refuses to generate content below the threshold for this artifact class. Every claim carries a citation chain back to RIG, audit-logged with HMAC integrity.

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