Challenges in regulating breakthrough medical devices

Food Drug Law J. 2005;60(2):137-42.

Authors

Neal I Muni¹, Thomas P Gross, Ashley B Boam, Stanley Wang, Bram D Zuckerman

Affiliation

¹ Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA), Rockville, MD, USA.

PMID: 16097092

No abstract available

MeSH terms

Device Approval / legislation & jurisprudence*
Documentation
Equipment Safety*
Humans
Product Surveillance, Postmarketing
Risk Management / legislation & jurisprudence*
United States
United States Food and Drug Administration