FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program.

Abstract

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