TPT provides supplemental Medicare outpatient (OPPS) payment for new devices for 2–3 years while CMS gathers utilization data to incorporate device costs into APC payment rates. Device pass-through applications can be filed quarterly, and CMS also reviews them in the annual OPPS rule. A device must not be described by an existing category, must be integral to a service, and must meet cost significance thresholds. Breakthrough Devices can qualify through an alternative pathway. Pass-through devices are billed with C codes.

Why it matters

Outpatient analog of NTAP. Highly important for ASC- and HOPD-administered procedures (structural heart, EP, ophthalmology).

Common pitfalls

•A common pitfall is misunderstanding the limited duration of TPT status, which is not a permanent reimbursement mechanism.
•Another mistake is failing to collect robust real-world evidence during the TPT period, which can hinder future APC rate setting.
•Companies sometimes misjudge the data submission requirements for continued TPT eligibility and eventual APC integration.
•Not all new devices are eligible for TPT, leading to misaligned expectations regarding reimbursement pathways.
•Failing to engage with CMS early can result in delays or missed opportunities for TPT consideration.

Sources

42 CFR § 419.66 : Transitional pass-through payments: Medical devices · eCFR

Open full page

Select term B to compare.

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.