Studies criticize U.S. medical device approval process

By Andrew M. Seaman NEW YORK (Reuters Health) - Information on the safety and effectiveness of medical devices before and after they are cleared by U.S. health regulators can be improved, according to two new studies. One study found many U.S. Food and Drug Administration (FDA)-cleared medical devices meant to be implanted in the body were not backed by publicly available evidence that they are similar to a device already on the market. ...



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