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Proceedings Paper

Medical device clinical trial: design, conduct, and analysis
Author(s): Richard P. Chiacchierini
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Paper Abstract

The collection and evaluation of sound clinical data are the basis of the approval process for many medical devices. This paper outlines those topics that a sponsor must carefully consider in an effort to provide a meaningful evaluation and interpretation of clinical data in support of medical device Premarket Approval applications (PMA).1-3

Paper Details

Date Published: 6 December 1994
PDF: 8 pages
Proc. SPIE 2307, Health Care Technology Policy I: The Role of Technology in the Cost of Health Care, (6 December 1994); doi: 10.1117/12.195457
Show Author Affiliations
Richard P. Chiacchierini, Center for Devices and Radiological Health/FDA (United States)


Published in SPIE Proceedings Vol. 2307:
Health Care Technology Policy I: The Role of Technology in the Cost of Health Care
Warren S. Grundfest M.D., Editor(s)

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