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.
Related terms
Shared paths + categoryRegulatory
510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
De Novo & Breakthrough Pathways
Regulatory
De Novo Classification Request(De Novo)
Pathway to classify novel low- to moderate-risk devices that lack a predicate.
De Novo & Breakthrough Pathways
Regulatory
Premarket Approval(PMA)
FDA's most stringent device marketing application, required for high-risk Class III devices.
De Novo & Breakthrough Pathways
Clinical & Trials
Investigational Device Exemption(IDE)
FDA authorization to use an investigational device in a clinical study.
Regulatory
Breakthrough Device Designation(BDD)
FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.
De Novo & Breakthrough Pathways · adjacent
Regulatory
Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub)
Voluntary mechanism to obtain FDA feedback before a formal premarket submission.
De Novo & Breakthrough Pathways · adjacent
Latest in MedTech
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
FDA·1AdvaMed·1AHRMM·1
- 1FDA Q-Sub guidanceVerifiedFDAfda.gov
- 2AdvaMed Code of EthicsVerifiedAdvaMedadvamed.org
- 3AHRMM - Healthcare Supply ChainVerifiedAHRMMahrmm.org
Inline markers like [1] jump to the matching reference above.