FDA PMA/PDP sign-off authority
This article was originally published in The Gray Sheet
Agency amends in a May 18 Federal Register notice the regulations for delegation of authority to allow division directors within the Office of Device Evaluation in FDA's Center for Devices and Radiological Health to approve, disapprove or withdraw approval of premarket approval applications and product development protocols. "As a result of reengineering initiatives within CDRH...this delegation will improve the efficiency of operations for these programs," the notice explains
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