FDA Breakthrough Devices Program
- Legal basis. Section 515B of the FD&C Act (21 U.S.C. 360e-3). The program replaced the Expedited Access Pathway and Priority Review, and FDA counts EAP-designated devices as part of it (FDA; CMS TCET notice, 89 FR).
- Eligibility. (1) The device provides more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition, and (2) it meets one of the following: it is a breakthrough technology; no approved or cleared alternatives exist; it offers significant advantages over existing alternatives; or its availability is in patients' best interest (Federal Register summary of 21 U.S.C. 360e-3(b)(2)). It applies to PMA, 510(k) and De Novo pathways.
- Benefits. Interactive feedback from FDA experts during development and prioritized review of submissions (FDA bulletin).
- Stats as of June 30, 2026. 1,320 designations (1,299 from CDRH, 21 from CBER) and 210 marketing authorizations (205 CDRH, 5 CBER) (FDA). 25 authorizations were granted in the first half of 2026 (FDA bulletin). By trade-press count, FY2022–FY2025 each saw roughly 164–166 designations, except about 145 in FY2023 (MedTech Dive, secondary source). Cardiovascular, neurology and orthopedics are the largest areas.
- Confidentiality. FDA generally does not disclose designations before marketing authorization unless the sponsor does (FDA).
- Governing guidance: FDA's final "Breakthrough Devices Program" guidance.
CMS Transitional Coverage for Emerging Technologies (TCET)
- Final notice CMS-3421-FN. CMS issued it Aug 7, 2024, published it Aug 12, 2024, and it took effect Aug 12, 2024 (CMS fact sheet; Federal Register).
- Eligibility. The device must be FDA-designated Breakthrough; fall within a Medicare benefit category; not already be subject to an NCD; and not be otherwise excluded by law or regulation. Most diagnostic lab tests and IVDs stay with Medicare Administrative Contractors (CMS fact sheet).
- Annual cap. CMS "anticipates accepting up to five TCET candidates per year," based on resources rather than statute. It expected about 8 nominations a year (Federal Register). Follow-on "similar devices" reportedly don't count against the limit (Sidley, secondary).
- Mechanics. Manufacturers self-nominate, starting with a non-binding letter of intent. CMS uses the NCD process and Coverage with Evidence Development, and aims to finalize an NCD within 6 months after FDA market authorization (CMS fact sheet).
How they relate
TCET is open only to FDA Breakthrough-designated devices. Breakthrough designation speeds the FDA side. TCET coordinates CMS coverage review in parallel so Medicare national coverage can follow soon after FDA authorization, which helps close the gap between clearance and reimbursement (Federal Register).
What does it mean for startups?
- Designation isn't market access. Only about 16% of designations (210/1,320) have reached authorization, so plan your evidence and reimbursement strategy early.
- TCET is narrow. It accepts about 5 a year, Medicare-relevant devices only, so pediatric devices and most consumer wellness wearables fall outside it. Neuro and cardiometabolic DHTs serving older adults are the most natural fit.
- Evidence-gap planning (fit-for-purpose study design, real-world data) is where scientific consulting adds value.
Sources
- FDA Breakthrough Devices Program — https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
- FDA bulletin, updated metrics — https://content.govdelivery.com/accounts/USFDA/bulletins/42740a1
- MedTech Dive (secondary) — https://www.medtechdive.com/news/fda-breakthrough-program-starts-fy2026-at-steady-pace/811671/
- CMS TCET fact sheet — https://www.cms.gov/newsroom/fact-sheets/final-notice-transitional-coverage-emerging-technologies-cms-3421-fn
- Federal Register TCET final notice — https://www.federalregister.gov/documents/2024/08/12/2024-17603/medicare-program-transitional-coverage-for-emerging-technologies
- Sidley (secondary) — https://www.sidley.com/en/insights/newsupdates/2024/08/cms-finalizes-transitional-coverage-for-emerging-technologies-pathway-procedures