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# FDA Breakthrough Device Designations Top 1,280
- URL: https://www.fdaweb.com/fda-breakthrough-device-designations-top-1-280/
- Published: 2026-06-05T12:00:00.000Z
- Updated: 2026-09-14T13:40:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161266

FDA says its breakthrough devices program has surpassed 1,280 designations since its launch, highlighting the growing use of the expedited pathway by medical device developers seeking to bring innovative technologies to patients with serious or life-threatening diseases.

According to [updated figures ](https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program?utm%5Fmedium=email&utm%5Fsource=govdelivery#metrics)released by FDA, the agency had granted a total of 1,284 breakthrough device designations. The vast majority of those designations — 1,264 — were awarded by CDRH while CBER accounted for 20 designations.

The figures include devices originally designated through the Expedited Access Pathway (EAP), the predecessor program that FDA folded into the Breakthrough Devices Program. The agency considers EAP products part of the current program because both initiatives were designed to speed development and review of technologies addressing unmet medical needs.

The latest data, which cover the first half of fiscal 2026 through March 31, indicate that manufacturers continue to seek breakthrough status at a steady pace. FDA publishes annual data showing designations across a range of clinical specialties, reflecting the program's broad adoption in areas such as cardiovascular disease, neurology, oncology, diagnostics and digital health.

While designation can provide manufacturers with enhanced interaction with FDA reviewers and opportunities for more efficient development and review, it does not guarantee eventual market authorization.

FDA reported that 198 breakthrough-designated products have ultimately received marketing authorization for indications consistent with their original breakthrough designation. Of those, 193 were authorized through CDRH and five through CBER.

The marketing authorization total suggests that about 15% of designated products have successfully navigated the regulatory process and reached the market, although many breakthrough-designated devices remain in development or under FDA review.

Created under the 21st Century Cures Act, the breakthrough devices program is intended to accelerate the development and review of technologies that may offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. The program has become one of FDA's flagship initiatives for encouraging medical technology innovation while providing patients earlier access to promising products.