FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program.
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DOI: 10.1001/jamainternmed.2025.2235
Abstract: Importance 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… read more here.
Keywords: breakthrough devices; fda; therapeutic devices; authorization ... See more keywords