Prior authorization (PA) is a payer process requiring providers to obtain approval - based on medical necessity criteria - before a service, procedure, or device is covered. Common for high-cost devices, advanced imaging, and many DTx/RPM services. Payers use clinical criteria such as their own policies, InterQual or MCG guidelines, and decisions can be appealed. CMS's 2024 Interoperability and Prior Authorization rule requires Medicare Advantage, Medicaid and some other plans to speed decisions and add electronic prior authorization interfaces in stages starting in 2026. Device companies often fund patient access support teams to help with paperwork.

Why it matters

PA is a major friction point for new technology adoption; clinical pathway and PA support tools are increasingly part of the manufacturer commercial model.

Common pitfalls

•Underestimating PA denial rates and appeal timelines when modeling commercial uptake.

Sources

CMS PA reform · CMS
CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) · CMS

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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.