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
fDate :
3/1/1990 12:00:00 AM
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;
Journal_Title :
Engineering in Medicine and Biology Magazine, IEEE
