Loading...
Skip to main content

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.

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

The following release information covers the three recent ORA DX releases over the last three quarters of the fiscal year. For information regarding prior releases, contact us via the ORAPP Contact Us page.

Release 19.0 – Multi-Factor Authentication (MFA) for ORAPP, Firm Search (FS), Inventory and Inspections Enhancements (May 2024)

  • ORAPP – Regulatory partners can:
    • access ORAPP via a new required 2-step MFA log in process, due to HHS security policy
    • learn more about ORAPP MFA via the new ORAPP Security Overview Knowledge Article (KA) available on the KA page
    • learn more about ORAPP MFA via the updated ORAPP Overview e-Learning course available on the Training menu
    • access an updated list of values for County via the Inventory and Inspection data sharing capabilities
  • System-to-System – Regulatory partners can:
    • access an updated list of values for County via the Inventory and Inspection data sharing capabilities

Release 18.0 – Firm Search (FS) and Firm History (FH), Training, Non-Contracted Inspections (NCIs) Enhancements (March 2024)

  • ORAPP – Regulatory partners can:
    • retrieve additional FH Data Elements related to Program Risks, Recalls, Samples, and Compliance Cases
    • learn more about the Partnership for Food Protection (PFP) Information Technology (IT) Workgroup (WG) via the new Knowledge Article (KA) available on the KA page
    • learn more about FS and FH via the updated Firm Search and Firm History e-Learning course available on the Training menu
    • view additional error messages when submitting NCIs
  • System-to-System – Regulatory partners can:
    • retrieve the Establishment Type and Industry Code end date via System-to-System (S2S aka NFSDX) FS capability
    • view additional error messages when submitting NCIs

Release 17.0 – Sample Receipt and Analysis, and Firm History (FH) Enhancements (January 2024)

  • ORAPP – Regulatory partners can:
    • access the following updated Sample Data Sharing e-Learning courses via the e-Learning page from the Training menu:
      • Sample Receipt and Analysis Overview
      • Sample Receipt and Analysis Guidance Materials Overview
      • Sample Receipt and Analysis Submission
      • Sample Receipt and Analysis Errors, Correction, and Resubmission
    • submit Nutritional Analysis and Nutritional Infant Formula (NIS/NIF) sample analysis data, expanding the total number of supported analysis types to 12
    • access an updated list of values for County via the Sample data sharing capabilities
  • System-to-System – Regulatory partners can:
    • retrieve FH related to Snapshot, Consumer Complaints, Inspections, and Investigations data elements to enhance firm data accessibility for activities like work planning
    • access an updated list of values for County via the Sample data sharing capabilities