Medical Devices
-
Information about FDA/CDRH Reorganization
We would like to inform you that the Center for Devices and Radiological Health (CDRH) reorganized the Office of Device Evaluation (ODE) and the newly renamed Office of In Vitro Diagnostics and Radiological Health (OIR). This change was made to allow branches within each office to focus on a more similar group of products.
Office of In Vitro Diagnostics and Radiological Health
OIR, formerly known as the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), reorganized on Oct. 1, 2012 to include two Divisions with integrated regulatory responsibilities aligned by product area: the Division of Mammography and Quality Standards (DMQS) and the Division of Radiological Health (DRH).
For more information about OIR: Office of In Vitro Diagnostics and Radiological Health
Office of Device Evaluation
The Office of Device Evaluation reorganized on Nov. 1, 2012, creating two new divisions: the Division of Surgical Devices and the Division of Neurological and Physical Medicine Devices. Across all review divisions, twelve new branches were added, allowing for greater focus on similar product groups within branches.
For more information about ODE: Office of Device Evaluation
Please share this information with members of your organization.
Sincerely,
Christy Foreman
Director, Office of Device Evaluation
Alberto Gutierrez
Director, Office of In Vitro Diagnostics and Radiological Health
Food and Drug Administration
Center for Devices and Radiological Health
Phone: 1-800-638-2041 or 1-301-796-7100
Email: dsmica@fda.hhs.gov
-
-
