Office of Regulatory Affairs Also referred to as: ORA
COVID-19 Information
The U.S. Food and Drug Administration’s Office of Regulatory Affairs (ORA) is the lead office for all agency field activities. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States. In pursuit of its mission, ORA also works with its state, local, tribal, territorial and foreign counterparts.
Recalls & Alerts |
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Compliance Manuals/Guides |
Inspection Manuals/Guides |