Experts Say FDA Should Abandon Approval Process

A panel of medical experts said the government should abandon its system for approving most medical devices in the U.S., because it offers patients no assurance of safety. Right now, the U.S. Food and Drug Administration uses a streamlined review, called 510(k), to approve products that are similar to those it has already approved and are on the market. The streamlined review, used for about 90 percent of medical device applications, including those for knee and hip replacement, takes about...Full Story
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