PubMed

FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program.

PMID: 40587167 · 2025-08-01

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학술지JAMA internal medicine

연도2025-08-01

PMID40587167

초록

Congress established the US Food and Drug Administration (FDA) Breakthrough Devices Program (BDP) in 2016 to promote technological innovation and facilitate patient access. However, the clinical and regulatory characteristics of FDA-designated breakthrough devices have not been assessed. To characterize technological novelty, FDA review times, and premarket and postmarket evidence requirements for therapeutic breakthrough-designated devices. This cross-sectional study analyzed publicly available

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