A 513(g) submission asks CDRH for FDA's opinion on the classification and regulatory requirements applicable to a specific product. Responses are non-binding but heavily relied upon by sponsors of borderline products. Anyone can make the request in writing under section 513(g) of the FD&C Act, and FDA aims to respond within 60 days. The answer does not clear the device, but it often settles whether a product is a device, which product code applies and whether a 510(k), De Novo or PMA is likely. A user fee applies.

Why it matters

Useful for software-only products, combination products, and wellness devices where the 'is-it-a-device?' answer drives the entire regulatory plan.

Common pitfalls

•Misinterpreting the non-binding nature of the FDA's response, leading to inappropriate regulatory strategies.
•Failing to provide sufficient detail about the device in the 513(g) submission, resulting in an unhelpful or generic FDA response.
•Delaying critical regulatory activities waiting for a 513(g) response, which is advisory and not a prerequisite for other submissions.
•Confusing a 513(g) submission with a Pre-Submission (Q-Submission), which has a different purpose and interaction model with the FDA.
•Assuming a 513(g) response guarantees market clearance or approval; it only provides information regarding classification and requirements.

Sources

FDA - Medical Devices · FDA
European Commission - Medical Devices · European Commission
IMDRF Documents · IMDRF

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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.