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Some Previously Approved Medical Devices are Skirting Past FDA Evaluation

Published May 8, 2012 on TMD

A loophole in federal law requires the FDA to approve some previously-recalled medical devices.

Now, the agency says it wants to see that changed.

Defective hip implant devices and transvaginal mesh devices went to market despite significant concerns over the safety of earlier models. In addition, thousands of Americans have been injured as a result. Sadly, a loophole in federal law could be to blame.

By law, the Food and Drug Administration is not required to review or approve medical devices that are “substantially equivalent” to previously approved models, so long as the prior model was not taken off the market pursuant to an FDA or court order. Since the device’s prior models were approved, and still available, the law allowed the new devices to skirt past the FDA without evaluation.

However, some regulators are calling on Congress to change this. This past February, the FDA’s chief medical-device regulator asked Congress to close this loophole stating that a medical device is five times more likely to be recalled for having safety problems if it is based on an earlier model that had a known design flaw.

His remarks came just weeks after House Democrats introduced a bill that would allow the FDA to reject medical devices if previous models had been subject to manufacturer recalls. The bills’ sponsors say the change will go a long way toward protecting patient health and safety.

Medical device manufacturers, however, see the proposal as unnecessary regulation. The Advanced Medical Technology Association, which lobbies on behalf of medical device makers, indicated that the proposed bill “will not contribute to patient safety.”

Further, most companies choose to issue a voluntary recall before their products become subject to FDA or court action.

Unsurprising, the bills’ sponsors strongly disagree. Each year, on average, the FDA approves 28 medical devices whose design is based on a previously recalled model. Although not all prove to be as dangerous or notorious as the DePuy hip implant or Johnson & Johnson’s transvaginal mesh, many still cause serious injuries.

It remains to be seen what actions Congress will take. Additional regulation and red tape may hinder the ability to move medical devices onto the market to help those who need them. On the other hand, without proper evaluation, defective devices could and do prove harmful to consumers they are intended to benefit.