Refuse to Accept (RTA) is FDA's authority to reject a premarket submission before substantive review when administrative or content requirements are not met. Under section 524B, FDA began RTA enforcement on October 1, 2023 for any cyber-device submission missing the statutory cybersecurity content (vulnerability monitoring plan, secure-by-design processes, SBOM, and any other required information). An RTA stops the review clock; the sponsor must resubmit with complete content.

Why it matters

RTA on cybersecurity content is fast and unforgiving. Most MedTech teams that have hit it underestimated the scope of what FDA expects in the SBOM, threat model, and vulnerability management plan, or treated the section 524B requirements as guidance rather than statute. Build the cybersecurity package alongside the rest of the submission and pre-flight it against the RTA checklist.

Common pitfalls

•Submitting an SBOM that lacks the CISA minimum elements or end-of-support information.
•Including a generic vulnerability management plan with no resourcing detail.
•Missing the cybersecurity labeling content required under 524B.

Sources

Refuse to Accept Policy for 510(k)s · FDA
FDA Cybersecurity Guidance (Sept 2023) · FDA
CISA - Healthcare and Public Health Sector · CISA

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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.