MedTech Terms
    The authoritative reference
    All terms

    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 the regulation says
    The FDA actively encourages Pre-Submission meetings to facilitate efficient medical device development and review, as outlined in the guidance document "Requests for Feedback on Medical Device Submissions and Meetings With Industry." These meetings allow for early dialogue between sponsors and the agency, clarifying regulatory expectations before a formal submission like an Investigational Device Exemption (IDE), 510(k), De Novo, or Premarket Approval (PMA).

    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.

    Examples

    • A startup developing a novel AI-powered diagnostic tool schedules a Pre-Submission meeting to discuss their clinical study design and data requirements with the FDA before initiating patient recruitment.
    • A medical device manufacturer planning a 510(k) submission for a modified device uses a Pre-Submission to clarify which performance testing standards are applicable and sufficient for demonstrating substantial equivalence.
    • A company seeking De Novo classification for a low-to-moderate risk device without a predicate uses a Pre-Submission to discuss the proposed special controls and risk mitigation strategies with the agency.
    Common pitfalls
    • •Assuming the FDA’s feedback in a Pre-Submission is a guarantee of future submission approval, as feedback is non-binding.
    • •Failing to prepare a comprehensive and well-organized meeting package, leading to less effective feedback from the FDA.
    • •Submitting a Pre-Submission too early in the development process without specific questions or data to discuss, making the interaction less productive.
    • •Neglecting to follow up on the FDA’s feedback provided during the Pre-Submission when preparing the actual marketing submission.
    • •Using a Pre-Submission solely as a progress check without clear, specific questions for the FDA to address.

    Frequently asked questions

    Sponsors can obtain feedback on various aspects, including study design protocols, appropriate predicate device selection, testing strategies, and interpretation of regulatory requirements relevant to their device.
    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    FDA·1AdvaMed·1AHRMM·1
    1. 1
      FDA Q-Sub guidance
      Verified
      FDAfda.gov
    2. 2
      AdvaMed Code of Ethics
      Verified
      AdvaMedadvamed.org
    3. 3
      AHRMM - Healthcare Supply Chain
      Verified
      AHRMMahrmm.org

    Inline markers like [1] jump to the matching reference above.