Dr. Elton Strauss Comments: “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. 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 10 months as opposed to the years a more complex review would take. "As a doctor, and as a surgeon, we are always looking for the better apparatus," said Dr. Elton Strauss, chief of adult reconstruction at The Mount Sinai Medical Center in New York. "We read what has been tested, we read what we think is going to be an improvement. We read about how this device has been used in other countries.” Learn more.
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