FDA Open to Public Comments on Medical Devices

After releasing its draft on the premarket approval process for medical devices, the federal agency will accept public comments until November 14th. The FDA has scheduled a public hearing on the matter for September 16, 2011.
The FDA decided to re-examine the manner in which medical devices are approved and placed on the market after numerous artificial hip devices, particularly the metal-on-metal hip devices, have experienced high failure rates and led to a dangerous medical condition known as metallosis.
Presently, many new medical devices are “fast tracked” for approval based on the fact that the new device closely resembles previously approved devices in terms of design and function. Opponents of the so-called fast tracking system note the high failure rates and the numerous recalls that have taken place in the last few years to argue that the system is flawed and puts patients and consumers at unnecessary risk.