Search

Your search keyword '"Kesselheim, Aaron S."' showing total 1 results
Start Over Author "Kesselheim, Aaron S." Region european union countries
1 results on '"Kesselheim, Aaron S."'

1. Regulation of Medical Devices in the United States and European Union.

Author

Kramer, Daniel B., Xu, Shuai, and Kesselheim, Aaron S.

Subjects
*MEDICAL equipment laws, *MEDICAL equipment safety measures, *CONFLICT of interests
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.

Published
2012
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results