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Legal and ethical issues in the regulation and development of engineering achievements in medical technology. I.

Authors
  • Bronzino, J D
  • Flannery, E J
  • Wade, M
Type
Published Article
Journal
IEEE engineering in medicine and biology magazine : the quarterly magazine of the Engineering in Medicine & Biology Society
Publication Date
Jan 01, 1990
Volume
9
Issue
1
Pages
79–81
Identifiers
PMID: 18238327
Source
Medline
License
Unknown

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.

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