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

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3 Author(s)
Bronzino, J.D. ; Biomed. Eng. Program, Trinity Coll. Hartford, CT, USA ; Flannery, E.J. ; Wade, M.

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.<>

Published in:

Engineering in Medicine and Biology Magazine, IEEE  (Volume:9 ,  Issue: 1 )