Title :
FDA rules for the medical device engineer
Author :
Munzner, Robert F.
Author_Institution :
Center for Devices & Radiol. Health, US Food & Drug Adm., Silver Spring, MD, USA
Abstract :
Since enactment of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act in 1976, the US Food and Drug Administration has implemented rules that impinge on the design and testing of virtually all medical devices. These rules are described. The availability of FDA staff for informal guidance is noted
Keywords :
biomedical engineering; FDA rules; Federal Food Drug and Cosmetic Act; Medical Device Amendments; US Food and Drug Administration; informal guidance; medical device engineer; Biomedical engineering; Data engineering; Design engineering; Drugs; Manufacturing; Medical diagnostic imaging; Medical tests; Silver; Springs; Testing;
Conference_Titel :
Biomedical Engineering., Proceedings of a Special Symposium on Maturing Technologies and Emerging Horizons in
Conference_Location :
New Orleans, LA
DOI :
10.1109/MTEHBE.1988.26391
