Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Availability

Résumé

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Procedures for Handling Post- Approval Studies Imposed by PMA Order." The guidance provides a standard format and content for submitting post-approval studies. The guidance is issued to help ensure that sponsors provide adequate information about the conduct of post-approval studies and that the Center for Devices and Radiological Health (CDRH) can properly track and evaluate post-approval studies.