title: The critical path to new medical devices.
authors.affiliation: FDA Center for Devices and Radiological Health, USA.
authors.forename: Binita
authors.initials: B
authors.lastname: Ashar
authors.forename: Mark
authors.initials: M
authors.lastname: Barnett
authors.forename: Daniel
authors.initials: D
authors.lastname: Schultz
mesh_terms: D018795:Device Approval / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D006078:Government Programs / Q000458:organization & administration*; D013673:Technology Assessment, Biomedical; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration* / Q000639:trends