FDA sets deadline for draft policy on post-approval studies of devices

07/1/2009 | Medical Devices Today

The FDA expects to introduce by September a draft policy document that offers guidance on designing post-approval studies for medical devices, according to Danica Marinac-Dabic, director of the Division of Epidemiology at the Center for Devices and Radiological Health's Office of Surveillance and Biometrics. She said the agency has requested AdvaMed to comment on a previous version of the document.

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