title: Medical device regulation in the European Union.
authors.affiliation: Food and Drug Administration, USA.
authors.forename: L R
authors.initials: LR
authors.lastname: Horton
mesh_terms: D005062:European Union; D049673:History, 20th Century; D006801:Humans; D007883:Legislation, Medical / Q000266:history* / Q000458:organization & administration; D013677:Medical Laboratory Science / Q000331:legislation & jurisprudence* / Q000592:standards; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence