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{
"item_title" : "Medical Devices",
"item_author" : [" Government Accountability Office "],
"item_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.",
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Medical Devices : FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer
Overview
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.
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Details
- ISBN-13: 9781492311447
- ISBN-10: 1492311448
- Publisher: Createspace Independent Publishing Platform
- Publish Date: September 2013
- Dimensions: 11.02 x 8.5 x 0.13 inches
- Shipping Weight: 0.37 pounds
- Page Count: 62
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