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    Q-Submission (Pre-Submission)

    Voluntary mechanism to obtain FDA feedback before a formal premarket submission.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    The Q-Submission Program lets sponsors request written feedback or a meeting with FDA on specific questions about a planned device study, submission, or test plan. Pre-Submissions are the most common Q-Sub type.

    What this means in practice

    Used to de-risk study protocols, predicate selection, performance test plans, and AI/ML change control plans before investing in execution. Strong Pre-Subs reduce review cycles later.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·2European Commission·1
    1. 1
      Q-Submission Program
      Verified
      FDAfda.gov
    2. 2
      FDA - Medical Devices
      Verified
      FDAfda.gov
    3. 3
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu

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