Legal and ethical issues in the regulation and development of engineering achievements in medical technology: a 2006 perspective.
Two papers, Legal and Ethical Issues in the Regulation and Development of Engineering Achievements in Medical Technology parts I and II were written in 1990 by three authors of diverse backgrounds and published in the IEEE Engineering in Medicine and Biology Magazine in March of the same year. Part I of the paper discusses the existing Food and Drug Administration (FDA) requirements that existed in 1990 to regulate the clinical trial process for medical devices, obtaining Marketing Approval and exceptions that may allow the use of unapproved devices. The paper discusses how the FDA has loosened some of the stringent regulations to further its goal of encouraging new development while protecting public health and maintaining ethical standards. Part H of the paper focuses on the ethical implications of the process of introducing a new technology to the market place, specifically in the usage of unapproved technologies for emergency use and feasibility studies. This paper discusses the topics covered in the two papers and the changes that have been made to the FDA guidelines since their publication in 1990.
Malloy
Allison
A
Systems and Computer Engineering Department, Carleton University, Ottawa, ON, Canada.
D033161:Government Regulation; D007880:Legislation, Drug / Q000941:ethics / Q000639:trends; D013677:Medical Laboratory Science / Q000941:ethics / Q000331:legislation & jurisprudence / Q000639:trends*; D014481:United States; D014486:United States Food and Drug Administration