title: The US Food and Drug Administration's New Regulatory Toolkit to Bring Medical Device Innovation Back to the United States.
authors: Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
authors: Malvina B
authors: MB
authors: Eydelman
authors: Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
authors: Tieuvi
authors: T
authors: Nguyen
authors: Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
authors: J Angelo
authors: JA
authors: Green
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies; D006801:Humans; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*