What FDA Breakthrough Devices Program - Expedited Pathways & Requirements (2026) requires
The FDA Breakthrough Devices Program provides expedited development, assessment, and review for devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. Benefits include priority review, interactive communication, and senior management engagement. Devices must still meet applicable safety and effectiveness standards with robust clinical evidence and post-market commitments.
Pillar: Medical & Healthcare · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
SHA-256 integrity: 2d9347d40b57ff2dc54b6ffd952ccf066642bd22139a17e5f47c1489a4ee8218
Primary Citations — 7 traced to source
- 21 USC Section 360e-3 (FD&C Act Section 515B) - Breakthrough Devices Program statutory basis (FDARA 2017)
- FDA Final Guidance - Breakthrough Devices Program (December 2018, updated 2023)
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