A Pre-Submission (Q-Sub) is a formal mechanism to obtain written FDA feedback on questions related to a planned IDE, 510(k), De Novo, or PMA submission, including study design, predicate selection, and testing strategy. The Q-Submission program lets companies ask FDA specific questions about testing, trials or regulatory pathway before filing. FDA usually meets within about 70 to 75 days of receipt. Feedback is not binding, but it reduces the risk of surprises during review.

Why it matters

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.

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.

Sources

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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.