--- title: "Q-Sub, Pre-Submission Meeting | MedTech Terms" description: "Formal FDA feedback request prior to a marketing or IDE submission. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Commercialization](/terms?cat=Commercialization) 6. / 7. Pre-Submission Meeting [All terms](/terms) Commercialization [Clinical Evidence](/ecosystems/clinical-evidence)[Global Markets](/ecosystems/global-markets)[Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer)Q-Sub # Pre-Submission Meeting Formal FDA feedback request prior to a marketing or IDE submission. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last 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](/terms/ide), 510(k), [De Novo](/terms/de-novo), or [PMA](/terms/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](/terms/ide) (IDE), 510(k), [De Novo](/terms/de-novo), or [Premarket Approval](/terms/pma) (PMA). ## What this means in practice Strongly recommended for novel devices, AI/ML [SaMD](/terms/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 What types of feedback can be obtained through a Pre-Submission meeting? Sponsors can obtain feedback on various aspects, including study design protocols, appropriate [predicate device](/terms/predicate-device) selection, testing strategies, and interpretation of regulatory requirements relevant to their device. Is a Pre-Submission meeting mandatory for all medical devices? How long does the Pre-Submission process typically take? ## 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 Breakthrough Device Designation(BDD) FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions. Adjacent lesson ](/terms/breakthrough-device?from=de-novo-and-breakthrough)[ Regulatory Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) Voluntary mechanism to obtain FDA feedback before a formal premarket submission. Adjacent lesson ](/terms/q-sub?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 3 of 11 Ecosystems (3) - [Clinical Evidence](/ecosystems/clinical-evidence) - [Global Markets](/ecosystems/global-markets) - [Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 AdvaMed· 1 AHRMM· 1 1. [1 FDA Q-Sub guidance 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 AdvaMed Code of Ethics Verified AdvaMed · advamed.org ](https://www.advamed.org/our-work/code-of-ethics/) 3. [3 AHRMM - Healthcare Supply Chain Verified AHRMM · ahrmm.org ](https://www.ahrmm.org/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Selling a connected device into health systems? Hospital procurement increasingly requires MDS2, SBOM, and security questionnaires - we help your team answer them confidently. [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 Commercialization Acronym Q-Sub Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=pre-submission) Learn in 60 seconds Card Lesson Quiz Formal FDA feedback request prior to a marketing or IDE submission. - · 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. Remember this Watch out: Assuming the FDA’s feedback in a Pre-Submission is a guarantee of future submission approval, as feedback is non-binding. Related terms - [Investigational Device Exemption(IDE) ](/terms/ide) - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [De Novo Classification Request(De Novo) ](/terms/de-novo) - [Premarket Approval(PMA) ](/terms/pma) You may also need Auto-suggested from Commercialization and shared keywords. - [Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) ](/terms/q-sub) - [Predetermined Change Control Plan(PCCP) ](/terms/ai-ml-pccp) - [513(g) Request for Information(513(g)) ](/terms/513g) - [Bayesian Trial Design ](/terms/bayesian-trial) - [Modular PMA ](/terms/pma-modular) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) [All Commercialization terms](/terms?cat=Commercialization) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)