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Medical Devices: FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer
Product Code:
9781492311447
ISBN13:
9781492311447
Condition:
New
$16.91
Medical Devices: FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer
$16.91
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.
| Author: Government Accountability Office |
| Publisher: Createspace Independent Publishing Platform |
| Publication Date: Sep 04, 2013 |
| Number of Pages: 62 pages |
| Binding: Paperback or Softback |
| ISBN-10: 1492311448 |
| ISBN-13: 9781492311447 |
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