FDA To Review Classification Of 25 Class III Devices

Law360, New York (April 8, 2009, 12:00 AM EDT) -- The U.S. Food and Drug Administration on Wednesday ordered manufacturers of 25 classes of medical devices determined to carry the highest level of risk to users to submit safety and effectiveness data so that the agency can do a complete review of the devices.

All the devices, including several pacemaker parts, hip prosthetics and the female condom, were marketed in the U.S. prior to 1990 amendments to the Medical Device Amendments to the Food, Drug and Cosmetic Act of 1976, the agency said in a statement....
To view the full article, register now.