Federal regulators announced last month that they would ask makers of some of the riskiest medical devices on the market to prove that their products were safe and effective. This is a step that critics of the Food and Drug Administration have said was long overdue. In January, the Government Accountability Office issued a report critical of the FDA for failing for decades to fix its system for reviewing categories of devices that have been on the market since before the enactment of the medical device law in 1976. Such “legacy devices,” as they are known, were originally allowed on the market with minimal testing. But Congress in the 1976 law told the FDA to gradually reclassify these older devices and decide which ones needed extensive testing before approval of new versions and which ones did not.
Unfortunately, the FDA never finished that process, and as a result 27 different types of devices were left unexamined. The products include artificial lung membranes, external defibrillators and various pacemaker components. For decades, the federal regulatory agency has approved devices in these categories for sale without demanding rigorous tests showing that they work safely. Investigators for the GAO stated that it’s imperative that the FDA take “immediate steps” to fix its system for approving such devices. The agency agreed and, according to a report in the Times, the FDA says it has already undertaken a review of two of these older device types. The FDA announced last month that it was requiring makers of the other 25 types of devices to submit information to the agency within 120 days, detailing the products’ safety and effectiveness.
It’s not known how long the reclassification process for the older devices will take. The FDA must review each device type separately and that could take some time. According to the New York Times, industry groups predict that the FDA will conclude that most of the products are not risky enough to warrant greater scrutiny. The Advanced Medical Technology Association, a trade association, takes the position that the device types subject to the notice have already been thoroughly reviewed by the FDA. But consumer advocates argue that the agency’s entire process for approving medical devices needs overhauling. Diana Zuckerman, president of the National Research Center for Women and Families, observed:
It’s great that the FDA is finally going to look at pre-1976 devices, but the bigger problem is the low standards for approving any and all devices without clinical trials or any proof of safety or effectiveness.
Based on knowledge gained in drug company litigation, I agree with the latter view. The FDA should make it a priority to upgrade its standards and procedures relating to the approval of medical devices. The agency simply hasn’t done its required job in that area of its responsibilities. Hopefully, there will be a total reform at the FHA during the Obama Administration.
Source: New York Times
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