title: The impact of regulation.
abstract: The medical device industry in the United States is facing a number of challenges, for example, work on Food and Drug Administration reform and a global move towards European-style regulation and harmonization. This article examines those challenges and their effect on the industry and on patients.
authors.affiliation: Health Industry Manufacturers Association, Washington, District of Columbia 20005, USA.
authors.forename: A H
authors.initials: AH
authors.lastname: Magazine
mesh_terms: D018795:Device Approval; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D007221:Industry / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*