One of the U.S. Food & Drug Administration's (FDA) responsibilities is to approve medical devices before they can be marketed. However, what many consumers don't realize is that not all medial devices go through a rigorous approval process if they are similar to devices already on the market. Known as a 510k review, this abbreviated process which allows medical device manufacturers to quickly launch their products, may soon be a thing of the past.

FDA orders review of 510k process

The FDA has said that the Institute of Medicine and the FDA's Center for Devices and Radiological Health will both review the 510k process that has come under considerable scrutiny by consumer advocates, members of Congress and patients who have been injured by dangerous medical devices they say lacked appropriate pre-market review. Originally intended to speed up the approval process for products such as bandages, wheelchairs and less inherently dangerous products, the process has morphed to include a quick review of medical devices – often to the detriment of end users.

The Institute of Medicine will study the overall process of how medical devices are reviewed in a 510k situation. The FDA's Center for Devices and Radiological Health will evaluate the current internal process and make recommendations for improvement. While those who have already been injured by a dangerous medical device say that the review is seriously past due, it may give future medical device patients a better chance to avoid medical device injuries.

GAO identifies medical device types that weren't fully analyzed

Part of what prompted the review was a report from the Government Accountability Office (GAO) which identified nearly two dozen types of medical devices that were approved without being completely analyzed. Those include dental implants, defibrillators, pacemakers, acetabular hip replacements and many more.

Adding to controversy is the recent resignation of the top FDA medical regulator, Dr. Daniel Schultz who has been accused of approving devices which should not have been and favoring the medical device industry over the Administration's goal of consumer safety.

Ironically, the Associated Press reported that Advanced Medical Technology Association (AMTA), which represents device makers like Medtronic Inc. and Boston Scientific Corp., and are continually recalling defective medical devices called the 510k process a "well-defined, science-driven method."