title: Medical Device Regulation: A Comparison of the United States and the European Union.
abstract: Medical device regulation is a controversial topic in both the United States and the European Union. Many physicians and innovators in the United States cite a restrictive US FDA regulatory process as the reason for earlier and more rapid clinical advances in Europe. The FDA approval process mandates that a device be proved efficacious compared with a control or be substantially equivalent to a predicate device, whereas the European Union approval process mandates that the device perform its intended function. Stringent, peer-reviewed safety data have not been reported. However, after recent high-profile device failures, political pressure in both the United States and the European Union has favored more restrictive approval processes. Substantial reforms of the European Union process within the next 5 to 10 years will result in a more stringent approach to device regulation, similar to that of the FDA. Changes in the FDA regulatory process have been suggested but are not imminent.
authors.affiliation: From the Department of Orthopaedics, University of Utah School of Medicine, Salt Lake City, UT.
authors.forename: Travis G
authors.initials: TG
authors.lastname: Maak
authors.forename: James D
authors.initials: JD
authors.lastname: Wylie
mesh_terms: D004864:Equipment and Supplies / Q000145:classification; D005062:European Union; D033161:Government Regulation; D006801:Humans; D062307:Medical Device Legislation; D009983:Orthopedic Equipment; D011358:Product Surveillance, Postmarketing; D014481:United States