All terms
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 the regulation says
The FDAWhat 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.Examples
- A MedTech manufacturer submits a Q-Submission to get FDA feedback on the statistical analysis plan for a novel clinical trial prior to patient enrollment.
- A company developing an AI/ML powered diagnostic device uses a Pre-Submission to discuss its algorithm change control plan with the FDA to ensure compliance with the agency's evolving guidance on AI/ML in MedTech.
- Before conducting extensive biocompatibility testing, a device developer uses a Q-Submission to confirm with the FDA that the proposed test battery and materials are acceptable.
Common pitfalls
- •Misunderstanding the FDA's expectations for Q-Submission content can lead to unproductive interactions and delays.
- •Failing to clearly articulate specific questions in a Q-Submission may result in general feedback that does not address the sponsor's core concerns.
- •Submitting a Q-Submission too late in the development cycle may limit the ability to incorporate FDA feedback effectively.
- •Not adequately preparing for a Q-Submission meeting, such as failing to provide pre-read materials or clearly define meeting objectives, can diminish its value.
Frequently asked questions
Sponsors can request written feedback or a meeting to discuss various topics, including planned device studies, submission strategies, or specific test plans. This feedback helps clarify FDA expectations and potential regulatory pathways.
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
Intended Use
The objective intent of the manufacturer regarding the use of the device.
De Novo & Breakthrough Pathways · adjacent
Regulatory
Breakthrough Device Designation(BDD)
FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.
De Novo & Breakthrough Pathways
Latest in MedTech
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
FDA·2European Commission·1
- 1Q-Submission ProgramVerifiedFDAfda.gov
- 2FDA - Medical DevicesVerifiedFDAfda.gov
- 3European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
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