The physician self-referral law (commonly Stark) prohibits physicians from referring Medicare patients to entities with which they (or immediate family) have a financial relationship for designated health services, unless an exception applies. Unlike the Anti-Kickback Statute, Stark is a strict liability civil law, so intent does not matter. Device companies feel it mainly through physician-owned entities and hospital arrangements.

Why it matters

Particularly relevant to physician-owned ASCs, distributorships (PODs in spine), and equipment leasing arrangements.

Common pitfalls

•A common pitfall is misunderstanding the broad definition of "financial relationship," which includes both ownership/investment interests and compensation arrangements.
•Another mistake is failing to document compliance with an applicable exception, as the burden of proof lies with the referring physician or entity.
•Companies often err by not conducting thorough due diligence on potential referral sources, leading to inadvertent violations.
•Assuming that an arrangement is permissible under other anti-fraud statutes, such as the Anti-Kickback Statute, means it will also satisfy Stark Law requirements, which is not always true.
•Failing to regularly review and update compliance programs for Stark Law adherence can result in outdated practices and potential non-compliance.

Sources

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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.

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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.

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