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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.

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 16.1 –Inventory Reconciliation (IR), Sample, and Training Enhancements (September 2023)

  • ORAPP – Regulatory partners can:
    • learn more about ORA DX capabilities via the new Knowledge Articles page available via the Training menu
    • learn more about IR via the new e-Learning courses
    • access e-Learning courses via the new ORAPP account distribution email
    • view updated instructions about accessing courses via e-Learning training page
  • System-to-System – Regulatory partners can:
    • submit Nutritional Analysis and Nutritional Infant Formula (NIS/NIF) Sample Analysis data via LBS Schema 17.0*

*Not available in Enhanced DX Client

Release 16.0 – Contracted Inspection (CI), Inventory Reconciliation (IR), Sample Receipt and Analysis, and Training Enhancements (July 2023)

  • ORAPP – Regulatory partners can:
    • return and view the Doing Business As (DBA) and State ID data from FDA (as applicable) per the IR process
    • see potential increase in the IR match outcomes due to matching of state DBA to FDA firm legal name
    • access improved Sample Analysis templates for DEC analysis data submission
    • update ORAPP account password to be at least 15-characters in length
  • System-to-System – Regulatory partners can:
    • submit “Percent of Components Received in Interstate” data to FDA via firm updates during CI submission

Release 15.0 – Content Management, Contracted Inspection, Produce Safety, Sample, and Training Enhancements (April 2023)

  • ORAPP – Regulatory partners can:
    • access updated data elements and list of values in Sample Excel templates for Sample Collections, Receipt, and Analysis data sharing
    • access the updated Contact Us page to provide additional information to improve user support by FDA
    • access the public Training e-Learning page containing e-Learning courses
    • learn more about the Sample Receipt, Sample Analysis, and System-to-System via the e-Learning courses
    • be aware that FDA is automatically notified when produce safety documents are submitted
  • System-to-System – Regulatory partners can:
    • submit Food Defense Plan Quick Check (FDPQC) inspection protocols data to FDA
    • receive establishment type, industry code, and season start/end month fields via Firm Search results