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.

Why it matters

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.

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.

Sources

Q-Submission Program · FDA
FDA - Medical Devices · FDA
European Commission - Medical Devices · European Commission

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Why compare MedTech terms side by side?

MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

How to use this tool

Pick term A and term B from the dropdowns, or click a preset above. The URL updates with both slugs so you can bookmark or share the exact comparison with a colleague, a notified body reviewer, or your regulatory consultant. Click Open full page on either side for the complete entry, including FAQs, related terms, and the full citation list. If you are not sure which term to start with, browse the Categories view or the A-Z index.

MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.