Q-Submission (Pre-Submission)
Voluntary mechanism to obtain FDA feedback before a formal premarket submission.
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. Q-Submission types include Pre-Submissions (Pre-Subs) for feedback on planned testing or protocols, Submission Issue Requests, Study Risk Determinations, Informational Meetings and Breakthrough Device designation requests. FDA aims to give written feedback for a Pre-Sub within about 70 days, or five days before a scheduled meeting. Feedback is not binding, but FDA generally intends to stay consistent with it unless circumstances or science change.What 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.
- •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
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 pathThe objective intent of the manufacturer regarding the use of the device.
FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.
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 4 of 11
Latest in MedTech
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.
- 1Q-Submission ProgramTier 2 VerifiedFDAfda.gov
- 2FDA - Medical DevicesTier 2 VerifiedFDAfda.gov
- 3European Commission - Medical DevicesTier 2 VerifiedEuropean Commissionhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.