FDAnews
www.fdanews.com/articles/138813-fda-is-urged-to-revamp-its-review-process-for-medical-devices

FDA Is Urged to Revamp its Review Process for Medical Devices

July 29, 2011
The Food and Drug Administration should stop permitting thousands of medical devices to be marketed and used in patients without proof of safety or effectiveness, the National Academy of Sciences said.
Los Angeles Times