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Medical Devices: FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer

Medical Devices: FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer( )
Author: Government Accountability Office,
ISBN:978-1-4923-1144-7
Publication Date:Sep 2013
Publisher:CreateSpace Independent Publishing Platform
Book Format:Paperback
List Price:USD $14.30
Book Description:

Medical devices are reviewed primarily by FDA's Center for Devices and Radiological Health (CDRH), with a smaller proportion reviewed by the Center for Biologics Evaluation and Research (CBER). FDA classifies each device type into one of three classes-class I, II, or III-based on the level of risk it poses and the controls necessary to reasonably ensure its safety and effectiveness.

Book Details
Pages:60
Physical Dimensions (W X L X H):8.5 x 11 x 0.14 Inches
Book Weight:0.46 Pounds

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