DocumentCode
1276643
Title
Legal and ethical issues in the regulation and development of engineering achievements in medical technology. I
Author
Bronzino, J.D. ; Flannery, E.J. ; Wade, M.
Author_Institution
Biomed. Eng. Program, Trinity Coll. Hartford, CT, USA
Volume
9
Issue
1
fYear
1990
fDate
3/1/1990 12:00:00 AM
Firstpage
79
Lastpage
81
Abstract
The statutory and regulatory requirements governing medical device development and approval are reviewed. Some of the procedures that the US Food and Drug Administration has implemented to loosen the strictures that impede development and approval of new medical devices are discussed. Some of the ethical issues associated with these procedures are examined.<>
Keywords
biomedical engineering; biomedical equipment; legislation; professional aspects; US Food and Drug Administration; engineering achievements; ethical issues; legal issues; medical device development; medical technology; regulatory requirements; statutory requirements; Biomedical engineering; Educational institutions; Food technology; Humans; Law; Legal factors; Medical diagnostic imaging; Pharmaceutical technology; Tellurium; Testing;
fLanguage
English
Journal_Title
Engineering in Medicine and Biology Magazine, IEEE
Publisher
ieee
ISSN
0739-5175
Type
jour
DOI
10.1109/51.62914
Filename
62914
Link To Document