The Anti-Kickback Statute (42 USC §1320a-7b) makes it a criminal offense to knowingly offer, pay, solicit, or receive remuneration to induce or reward referrals of items or services payable by federal healthcare programs. Safe harbors define protected arrangements. The statute makes it a crime to offer or pay anything of value to induce referrals of federal health care business. Safe harbors protect certain arrangements, such as properly structured discounts and personal services. Violations can lead to fines, prison and exclusion from federal programs.

Why it matters

AKS shapes nearly every MedTech commercial program - physician consulting, training grants, KOL engagement, product loans, GPO contracting. Violations carry criminal, civil, and exclusion penalties.

Common pitfalls

•Misinterpreting safe harbor provisions can lead to non-compliance, as strict adherence to all conditions is required for protection.
•Assuming that an arrangement is permissible simply because it is common practice in the industry is a significant pitfall.
•Failing to properly document the fair market value and legitimate business purpose of all remuneration can lead to scrutiny and potential violations.
•Not understanding the broad definition of "remuneration" beyond direct payments, which can include gifts, free services, or excessive compensation, is a common mistake.
•Neglecting to consider state anti-kickback laws, which may impose stricter requirements than the federal AKS, can result in legal issues.

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.