Medical Devices: FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer
||Government Accountability Office, |
|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.