Pre-Submission Meeting
Formal FDA feedback request prior to a marketing or IDE submission.
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. The Q-Submission program lets companies ask FDA specific questions about testing, trials or regulatory pathway before filing. FDA usually meets within about 70 to 75 days of receipt. Feedback is not binding, but it reduces the risk of surprises during review.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.
- •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
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Pathway to classify novel low- to moderate-risk devices that lack a predicate.
FDA's most stringent device marketing application, required for high-risk Class III devices.
FDA authorization to use an investigational device in a clinical study.
De Novo & Breakthrough Pathways
· From this learning pathFDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.
Voluntary mechanism to obtain FDA feedback before a formal premarket submission.
Product comprised of two or more regulated components - e.g., drug-device, biologic-device.
Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate.
Where this term appears across MedTech Terms.
- De Novo & Breakthrough PathwaysLesson 3 of 11
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Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1FDA Q-Sub guidanceTier 2 VerifiedFDAfda.gov
- 2AdvaMed Code of EthicsTier 4 VerifiedAdvaMedadvamed.org
- 3AHRMM - Healthcare Supply ChainTier 4 VerifiedAHRMMahrmm.org
Inline markers like [1] jump to the matching reference above.