The Sunshine Act (Open Payments program) requires manufacturers of drugs, devices, biologics, and medical supplies covered by Medicare/Medicaid/CHIP to report transfers of value to physicians, certain non-physician practitioners, and teaching hospitals. Reports go to CMS Open Payments each year and the data is published. Companies track payments for meals, consulting, travel and research, and reporting errors can lead to civil penalties.

Why it matters

Reported annually by CMS and publicly searchable. Mis-reporting creates reputational and enforcement risk; KOL agreements must be FMV and well-documented.

Common pitfalls

•Failing to accurately categorize transfers of value can lead to misreporting and penalties.
•Inadequate documentation of fair market value for key opinion leader (KOL) agreements can result in non-compliance.
•Overlooking indirect payments or transfers of value made through third parties can lead to enforcement actions.
•Not understanding the specific definitions of "applicable manufacturer" and "covered recipient" can lead to reporting errors.

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.