The designation
21 U.S.C. §360e-3 — the designation criteria, what it gives (expedited development, priority review), and what it doesn't.
Free field guide · PDF
Breakthrough Device & RAPID Coverage2026 Field Guide
The designation, the coverage bridge, and the NTAP closure — with the breakthrough practice you need.
- Median gap
- ~6 yrs
- RAPID target
- 2 months
- Eligible devices
- ~40
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The RAPID bridge
Announced 23 April 2026: authorization-to-coverage in as little as two months — eligibility, and the TAP link.
The NTAP closure
For applications on or after 1 October 2026, extra hospital payments need demonstrated substantial clinical improvement.
Sources & scope
- jdsupra.com, CMS and FDA Announce New RAPID Program for Medicare Coverage of Breakthrough Medical Devices (Apr 2026).
- jdsupra.com, RAPID Response: CMS and FDA Team Up to Fast-Track Medicare Coverage.
- medicaldaily.com, Medicare Will Require Breakthrough Devices to Prove Substantial Clinical Improvement.
- medicaldesignandoutsourcing.com, FDA, CMS unveil RAPID Medicare coverage pathway.
This guide is market-access intelligence, not regulatory or legal advice. Designation criteria, coverage pathways, and payment rules change — professional review is required before business use.
Market Access Strategy Session
Breakthrough on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your breakthrough strategy — designation readiness, evidence planning, and coverage timing.
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