Under ORA’s new program-based management model, there are seven key programs for operations (Biological Products, Bioresearch Monitoring, Human and Animal Food, Medical Devices and Radiological Health, Pharmaceutical Quality, Tobacco and Imports). Each program has a unique number of program divisions for a total of 28 operational divisions.
ORA’s laboratories will also specialize and align into Human and Animal Food labs or Medical Product, Tobacco, and Specialty labs.
ORA’s 20 districts are being retained and our district directors will continue to lead and manage the district overall, but are also aligned operationally within a single program.
Below are the programmatic division boundary maps for ORA operations and a map of ORA’s laboratory locations.
The Fact Sheets will provide you with an overview of each office's responsibilities and functions.
Below are the seven program division boundary maps, a map of ORA’s laboratory locations, and FDA External Fact Sheets.
Office of Bioresearch Monitoring Operations (OBIMO)
Office of Biological Products Operations (OBPO)
Office of Medical Device and Radiological Health Operations (OMDRHO)
Office of Pharmaceutical Quality Operations (OPQO)
Office of Human and Animal Food Operations (OHAFO)
Office of Enforcement and Import Operations (OEIO)
Tobacco Operations Program
ORA Laboratory Locations, Office of Regulatory Science (ORS)