title: Breakthrough Medical Devices and the 21st Century Cures Act.
authors.forename: Aaron S
authors.initials: AS
authors.lastname: Kesselheim
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Hwang
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004059:Diffusion of Innovation; D006291:Health Policy; D006801:Humans; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration