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# FDA Updates Breakthrough Device Statistics
- URL: https://www.fdaweb.com/fda-updates-breakthrough-device-statistics/
- Published: 2025-08-20T12:00:00.000Z
- Updated: 2026-09-14T15:19:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159724

Since its 2015 inception, the FDA Breakthrough Devices program has granted 1,176 breakthrough device designations, 1,157 from CDRH and 19 from CBER. Updated program [metrics](https://content.govdelivery.com/accounts/USFDA/bulletins/3ee6bbf?ref=fdaweb.com) also show that the agency has granted 160 marketing authorizations since 2015.