The Office of Regulatory Affairs Data Exchange (ORA DX) securely shares information between the Food and Drug Administration (FDA) and state and local regulatory partners. Under FDA's continued efforts to implement the Food Safety Modernization Act (FSMA), the ORA DX mission is to streamline submission of food safety regulatory data and support timely decision-making by providing access to relevant inventory, sample, and inspection information.
Participation in the ORA DX provides regulatory partners with the following benefits:
The ORA DX is a unified platform of the following two systems that facilitate secure, electronic data exchange:
An Enhanced DX Client is also available as a downloadable desktop application that allows regulatory partners to submit sample (lab) data to FDA. For more information on the ORA DX systems and onboarding, please refer to the ORA DX Program Overview factsheet.