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Proceedings Paper

Reinventing device review
Author(s): Lynne A. Reamer
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Paper Abstract

Changes over the last twelve months in the Office of Device Evaluation have created an atmosphere that is open to trying a new approach to device review. Statistics from the last two years are presented with emphasis on the 510(k) application. Initiatives that are already in place are described and new strategies are shared that will potentially lead to a more streamlined review process. One division's efforts are outlined and include elimination of a layer of management, reorganization of the staff, and the development of standard operating procedures for 510(k) review. The entire process has been flow-charted and from the flow chart, steps that can be modified or eliminated can be identified. Total quality management has been introduced as one of the tools to achieve success.

Paper Details

Date Published: 27 October 1995
PDF: 12 pages
Proc. SPIE 2499, Health Care Technology Policy II: The Role of Technology in the Cost of Health Care: Providing the Solutions, (27 October 1995); doi: 10.1117/12.225315
Show Author Affiliations
Lynne A. Reamer, U.S. Food and Drug Administration (United States)


Published in SPIE Proceedings Vol. 2499:
Health Care Technology Policy II: The Role of Technology in the Cost of Health Care: Providing the Solutions
Warren S. Grundfest, Editor(s)

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