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ORA Data Exchange Overview

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. For more information on the ORA DX systems and onboarding, please refer to the ORA DX Program Overview factsheet.

The ORA Data Exchange has three main capabilities: Inventory Data Sharing, Inspection Data Sharing, and Sample Data Sharing. Inventory Data Sharing: Provides regulatory partners robust inventory related capabilities to search and view FDA’s inventory, share inventory with other regulatory partners and exchange Produce Safety Farm Inventory with FDA. Inspection Data Sharing: Regulatory partners can submit Contracted Inspection results including attachments and Non-Contracted Inspection results to FDA, thereby reducing double data entry. Sample Data Sharing: Provides regulatory partners flexible options for submitting Sample Collection, Analysis and Receipt data leading to improved information sharing for faster compliance decisions by FDA.

Recent Releases

Release 11.0 – Inventory Reconciliation and Firm Search Enhancements (January 2022)

  • ORAPP – Regulatory partners can:
    • support state Inventory Reconciliation by submitting state firm inventory data and receiving a list of matches with FDA firm inventory
    • sort on Firm Search query results fields in the tabular display
    • view additional Firm History data elements (not previously available in ORAPP) related to consumer complaints, inspections, investigations, Corrective Action Reports (CAR), and registrations
    • learn more about ORA DX inspection and firm inventory data sharing capabilities on new publicly available overview pages

Release 10.1 – Samples Receipt and Analysis Enhancements (September 2021)

  • System-to-System, ORAPP, and Enhanced DX Client – Regulatory partners can:
    • submit Antibiotics (ANT) analysis results to FDA

Release 10.0 – Samples Receipt and Analysis Enhancements (September 2021)

  • System-to-System, ORAPP, and Enhanced DX Client – Regulatory partners can:
    • submit Narrative (NAR) analysis results to FDA
    • use the new PAC length for Sample capabilities and Non-Contracted Inspections (NCI)