Medical Devices and Radiological Health FY2015 Program Alignment Action Plan

Ajit Basrur

The following Medical Devices and Radiological Health FY2015 Action Plan (the Action Plan), developed by the Center for Devices and Radiological Health (CDRH) and the Office of Regulatory Affairs (ORA) is intended to facilitate increased operational and program alignment as FDA transitions to distinct commodity-based and vertically-integrated regulatory programs with well-defined leads, coherent policy and strategy development, and well-designed and coordinated implementation. Core elements of the Action Plan include increased specialization and de-layered management structures and processes involving ORA and CDRH, jointly developed training programs, new work planning processes, strategic enforcement approaches with aligned and updated compliance programs and policy, strategic import approaches, laboratory optimization, and improved information technology systems. Coordination of internal and external communication on the Action Plan will ensure that FDA speaks with one voice on the policies and operations related to the medical device and radiological health program. This Action Plan has been reviewed by CVM to ensure alignment with respect to veterinary devices and products.



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