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:
- Increases efficient electronic data exchange between FDA and regulatory partners
- Increases collaboration and the support of the FDA vision for Mutual Reliance
- Reduces dual data entry in regulatory partner system and FDA system
The ORA DX is a unified platform of the following two systems that facilitate secure, electronic data exchange:
- System-to-System (aka National Food Safety Data Exchange - NFSDX) - web services that provide bi-directional communication between FDA IT systems and regulatory partner IT systems
- ORA Partners Portal (ORAPP) - a website that allows FDA regulatory partners to view and submit regulatory data through a comprehensive web-based user interface
An Enhanced DX Client is also available as a downloadable desktop application that allows regulatory partners to submit sample (lab) data to FDA.