title: Industry perspective on FDA regulation of medical devices and the practice of medicine.
authors.affiliation: Technology and Regulatory Affairs, Health Industry Manufacturers Association, Washington, District of Columbia 20005, USA.
authors.forename: M K
authors.initials: MK
authors.lastname: Tandy
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D007221:Industry; D014481:United States; D014486:United States Food and Drug Administration