title: Ethical issues in the regulation and development of engineering achievements in medical technology-a regulatory perspective.
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.
authors.affiliation: Biometric Res. Inst. Inc., Arlington, VA.
authors.forename: G A
authors.initials: GA
authors.lastname: Rahmoeller