FDA Under Scrutiny

The FDA is said to have approved risky medical devices without proper review.

The Food and Drug Administration (FDA) has been accused of placing thousands of people at risk by approving certain potentially hazardous medical devices for use without adequate review, as reported by the Associated Press (AP). In 1976, Congress set up a classification system for medical devices. Items such as tongue depressors, reading glasses and bandages were classified as low risk devices and could get approval from the FDA simply by notifying the FDA before putting them on the market. Pacemakers, heart valves, silicone breast implants or any device that could cause death were classified as high risk devices and were supposed to go through intense testing and observation before being placed on the market. Newer or updated versions of devices that were already approved were not scrutinized and could get approved by the FDA by simply claimed they were basically the same as the prior version. In 1990, the FDA was ordered by Congress to treat updated versions of devices the same as they would an original device and undergo thorough testing. However the agency has allegedly failed to do as Congress ordered.

According to the Government Accountability Office, 228 high risk devices such as metal hip joints, external defibrillators, and electrodes for pacemakers were approved without proper testing. Although the FDA acknowledged the claims and agreed it needs to be corrected, they have not set any timetable to correct the problem. Peter Lurie, deputy director of Public Citizens health research group is quoted in the AP report as stating “It all adds up to less than rigorous device review and it’s placing tens of thousands of Americans at risk.

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