Back to Search
Start Over
Regulation of Medical Devices in the United States and European Union.
- Source :
-
New England Journal of Medicine . 3/1/2012, Vol. 366 Issue 9, p848-855. 8p. - Publication Year :
- 2012
-
Abstract
- The article compares the medical device regulations in the U.S. and the European Union (EU). High-risk device manufacturers in the U.S. are required by the Food and Drug Administration (FDA) to demonstrate safety and effectiveness before they can market their products. In Europe, patients have access to high-risk medical devices such as replacement joints and coronary stents. Criticisms against the EU system for conflicts of interest in its evaluation process are discussed.
- Subjects :
- *MEDICAL equipment laws
*MEDICAL equipment safety measures
*CONFLICT of interests
Subjects
Details
- Language :
- English
- ISSN :
- 00284793
- Volume :
- 366
- Issue :
- 9
- Database :
- Academic Search Index
- Journal :
- New England Journal of Medicine
- Publication Type :
- Academic Journal
- Accession number :
- 72401162
- Full Text :
- https://doi.org/10.1056/NEJMhle1113918