Two leading medical journals have found weaknesses in how the Food and Drug Administration approves cardiovascular medical devices. The journals say some products reached the market based on tests that were inadequate and open to bias. The studies came as the FDA was facing intense pressure to overhaul the medical-device approval process.
The FDA says it is developing guidelines that will set tougher scientific standards for data from tests on humans that makers of medical devices submit when seeking approval of their products. Dr. Jeffrey Shuren, the acting director of the Center for Devices and Radiological Health, says that the FDA most likely will soon urge device makers to take steps like using more sharply-defined targets to measure the success of clinical trials. The agency may also urge producers to more closely follow patients enrolled in such trials to determine whether the targets are met, according to Dr. Shuren.
Manufacturers should be made to know exactly what is expected of them and then the FDA should make sure they comply. The FDA is beginning to recognize the problems and hopefully will take the steps necessary to see that this happens. Clearly, the FDA must raise its clinical trial standards for medical devices. The data produced by trials must be reliable. If the data aren’t reliable, the risks for severe problems greatly increase. Hopefully, the FDA will do the right thing and protect the public.
Source: Wall Street Journal
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