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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 efforts to implement the Food Safety Modernization Act, 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 two systems that facilitate secure, electronic data exchange:

  • ORA Partners Portal (ORAPP), a website that allows FDA regulatory partners to view and submit regulatory data through a comprehensive web-based user interface.
  • National Food Safety Data Exchange (NFSDX), a system-to-system web service that provides bi-directional communication between FDA IT systems and regulatory partner IT systems.

Also available is the Enhanced DX Client, 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

Release 9.0 – Contracted Inspection (CI) Enhancements (July 2021)

  • NFSDX - Regulatory partners can:
    • update firm's point of contact (POC) information including the Top Management Official (TMO) POC designations for Contracted Inspection (CI) firm data
    • submit Intentional Adulteration (IA) data for CI
    • submit attachment up to size 250 MB for CI
    • use the new Program/Assignment Code (PAC) length for CI

Release 8.2 – Sample Enhancements (March 2021)

  • NFSDX, ORAPP, and Enhanced DX Client - Regulatory partners can:
    • use the updated Sample Receipt and Analysis Excel Template to submit sample receipt and analysis data
      • Includes look-up abbreviations list of values (LOVs) and dynamic dropdown lists
      • Includes additional data elements "Genus" and "Analysis Status"
    • download the new Sample Receipt and Analysis Excel Template (v 2.2) and the Sample Collection Excel Template (v 1.1) from ORAPP
    • and must use the latest templates for Samples data submission to FDA via ORAPP

Release 8.1 – Contracted Inspection Attachments (January 2021)

  • NFSDX – Regulatory partners can:
    • submit attachments for an inspection
    • delete attachments from an inspection
    • retrieve a list of attachments associated with an inspection