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The U.S. Food and Drug Administration (FDA) today unveiled a new Web page that will keep the public informed about the status of post-approval patient studies for certain recently approved medical devices.
"FDA is committed to improving its medical device safety program and ensuring that medical devices remain safe and effective once they are in the hands of health professionals and the public," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "Electronic access will give the public an opportunity to see progress being made on a company's post-market commitments."
Modern devices provide significant health benefits, but experience has shown that the full magnitude of some potential risks doesn't always emerge during the mandatory clinical trials that are required for approval. FDA sometimes orders post-approval studies to address remaining issues such as the product's performance once it becomes more widely available or is used over a longer period of time.
Source: FDA Provides Web Access to Information on Post-Approval Device Studies
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