FDA Provides Web Access to Information on Post-Approval Device Studies

by Sabrina I. Pacifici on April 6, 2007

Press release: “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…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.”

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