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