Title :
Ethical issues in the regulation and development of engineering achievements in medical technology-a regulatory perspective
Author :
Rahmoeller, G.A.
Author_Institution :
Biometric Res. Inst. Inc., Arlington, VA, USA
fDate :
6/1/1988 12:00:00 AM
Abstract :
A description is given of the ethical issues encountered by the US Food and Drug Administration (FDA) in its regulation of new life-saving devices. Issues related both to clinical investigation and to marketing approval of the devices are examined. The potential role of engineers in addressing these issues is discussed.<>
Keywords :
biomedical engineering; reviews; US Food and Drug Administration; clinical investigation; life-saving devices; marketing approval; Biomedical engineering; Biometrics; Control systems; Drugs; Heart valves; Medical control systems; Medical treatment; Pharmaceutical technology; Prosthetics;
Journal_Title :
Engineering in Medicine and Biology Magazine, IEEE
