Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.
The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to reflect a new delegation that authorizes the Division Directors, Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) to approve, disapprove, or withdraw approval of product development protocols and applications for premarket approval for medical devices.
D003659:Decision Making, Organizational; D018795:Device Approval; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*