title: Regulation of medical devices in the United States and European Union.
authors.affiliation: Harvard Medical School, and Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, USA.
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Kramer
authors.forename: Shuai
authors.initials: S
authors.lastname: Xu
authors.forename: Aaron S
authors.initials: AS
authors.lastname: Kesselheim
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D005062:European Union; D033161:Government Regulation; D012306:Risk; D014481:United States; D014486:United States Food and Drug Administration