--- title: "Q-Sub / Pre-Sub Definition & Meaning | MedTech Terms" description: "Voluntary mechanism to obtain FDA feedback before a formal premarket submission. Plain-English Regulatory definition for MedTech teams, with examples and relate" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/q-sub#term", "name": "Q-Submission (Pre-Submission)", "alternateName": "Q-Sub / Pre-Sub", "description": "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. 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[Regulatory](/terms?cat=Regulatory) 6. / 7. Q-Submission (Pre-Submission) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)Q-Sub / Pre-Sub # Q-Submission (Pre-Submission) Voluntary mechanism to obtain FDA feedback before a formal premarket submission. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last 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](/terms/pre-submission) type. What the regulation says The FDA ## What this means in practice Used to de-risk study protocols, predicate selection, performance test plans, and AI/ML [change control](/terms/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 What types of feedback can be requested through a Q-Submission? 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. How does a Q-Submission differ from a traditional submission like a 510(k)? Is a Q-Submission binding on the FDA? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory De Novo Classification Request(De Novo) Pathway to classify novel low- to moderate-risk devices that lack a predicate. ](/terms/de-novo)[ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma)[ Clinical & Trials Investigational Device Exemption(IDE) FDA authorization to use an investigational device in a clinical study. ](/terms/ide) ### De Novo & Breakthrough Pathways · From this learning path [ Regulatory Intended Use The objective intent of the manufacturer regarding the use of the device. Adjacent lesson ](/terms/intended-use?from=de-novo-and-breakthrough)[ Regulatory Breakthrough Device Designation(BDD) FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions. ](/terms/breakthrough-device?from=de-novo-and-breakthrough)[ Regulatory Combination Product Product comprised of two or more regulated components - e.g., drug-device, biologic-device. ](/terms/combination-product?from=de-novo-and-breakthrough)[ Regulatory Indications for Use(IFU (statement)) Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate. ](/terms/indications-for-use?from=de-novo-and-breakthrough) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [De Novo & Breakthrough Pathways](/paths/de-novo-and-breakthrough)Lesson 4 of 11 Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 2 European Commission· 1 1. [1 Q-Submission Program Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program) 2. [2 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) 3. [3 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym Q-Sub / Pre-Sub Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=q-sub) Learn in 60 seconds Card Lesson Quiz Voluntary mechanism to obtain FDA feedback before a formal premarket submission. - · 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. - · Pre-Submissions are the most common Q-Sub type. Remember this Watch out: Misunderstanding the FDA's expectations for Q-Submission content can lead to unproductive interactions and delays. Related terms - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Premarket Approval(PMA) ](/terms/pma) - [Investigational Device Exemption(IDE) ](/terms/ide) - [De Novo Classification Request(De Novo) ](/terms/de-novo) You may also need Auto-suggested from Regulatory and shared keywords. - [Pre-Submission Meeting(Q-Sub) ](/terms/pre-submission) - [513(g) Request for Information(513(g)) ](/terms/513g) - [Modular PMA ](/terms/pma-modular) - [Device Reclassification Petition ](/terms/reclassification-petition) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [Request for Designation(RFD) ](/terms/rfd) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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