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    Pre-Submission Meeting

    Formal FDA feedback request prior to a marketing or IDE submission.

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

    Definition

    A Pre-Submission (Q-Sub) is a formal mechanism to obtain written FDA feedback on questions related to a planned IDE, 510(k), De Novo, or PMA submission, including study design, predicate selection, and testing strategy.

    What this means in practice

    Strongly recommended for novel devices, AI/ML SaMD, and any submission with non-obvious questions. Free, but timeline (~70–75 days) must be planned into program schedule.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·1AHRMM·1AdvaMed·1
    1. 1
      FDA Q-Sub guidance
      Verified
      FDAfda.gov
    2. 2
      AHRMM - Healthcare Supply Chain
      Verified
      AHRMMahrmm.org
    3. 3
      AdvaMed Code of Ethics
      Verified
      AdvaMedadvamed.org

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