The KEV Catalog lists CVEs with evidence of exploitation in the wild and actionable remediation guidance. Entries include affected products, date added, required action, due date, ransomware-use status and, where applicable, forensic-triage requirements. As of November 1, 2026, applicable federal requirements are governed by BOD 26-04, which superseded BOD 22-01 on June 10, 2026. Consult current directive requirements and each entry rather than assuming a universal 21-day deadline.

Why it matters

For device manufacturers, cross-reference KEV against component inventories and SBOMs, then assess affected versions, configuration, exploitability, patient impact and mitigations. KEV complements rather than replaces risk analysis.

Common pitfalls

•Treating CVSS score as a substitute for KEV status, many critical-CVSS bugs are never exploited; many medium-CVSS bugs on KEV are devastating.
•Polling KEV manually instead of automating ingestion of the official JSON feed and cross-referencing it with your SBOM.
•Do not assume federal KEV deadlines bind private hospitals or manufacturers. Assess applicable contracts and device-specific risk separately.

Sources

Known Exploited Vulnerabilities Catalog · CISA
Binding Operational Directive 22-01 · CISA
KEV JSON feed · CISA
CISA BOD 26-04 · CISA
CISA revoked BOD 22-01 · CISA
FDA final guidance, February 3, 2026 · FDA

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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.