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Medical Devices: FDA Should Enhance Its Oversight of Recalls
Medical Devices: FDA Should Enhance Its Oversight of Recalls
 
Our Price: $25.00
By Marcia Crosse
Year: 2011
Pages: 57
Binding Paperback
ISBN 9781437988062

Product Code: 1437988067

Description
 
Recalls are an important tool to mitigate serious health consequences associated with defective or unsafe medical devices. Typically, a recall is voluntarily initiated by the firm that manufactured the device. The FDA oversees implementation of the recall. FDA classifies recalls based on health risks of using the recalled device. FDA also determines whether a firm has effectively implemented a recall, and when a recall can be terminated. This report identifies: (1) the numbers and characteristics of medical device recalls and FDA's use of this info. to aid its oversight; and (2) the extent to which the process ensures the effective implementation and termination of the highest-risk recalls. Charts and tables. A print on demand report.

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