Less Than the Sum of Its Parts: Reforms Needed in the Organization, Management, and Resources of the Food and Drug Administration's Center for Devices and Radiological Health : a Report, Volume 4

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U.S. Government Printing Office, Jan 1, 1993 - Medical instruments and apparatus - 246 pages
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Contents

Executive Summary
1
Case Studies in FDAs Enforcement and
21
A Programmatic Review of the Device Evaluation
37
Other Limitations
57
Part of the Problem
65
Industry Perspectives
77
Recommendations
85
March 29 1993 memo from Acting Deputy Director HFZ10 to Claudia
93
Questionnaire for Office of Device Evaluation Reviewer
164
Summary of Reviewer Questionnaire
170
CDRH Listening Report
177
Calculation of ODE Workload
190
CDRH Management Action Plan
196
January 21 1993 Letter to the Medical Device Industry from Ronald Johnson
214
Transfer of OST FTES to ODE
221
XUI March 8 1993 Letter from Dr William W ONeill to Mr Reid Stuntz
231

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