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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

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

  • ORAPP – Regulatory partners can:
    • access updated data elements and list of values in Sample templates
    • access the updated Contact Us page
    • access the public Training page containing e-Learning courses
    • leverage the new e-Learning courses about Sample Receipt, Sample Analysis and System-to-System
  • System-to-System – Regulatory partners can:
    • submit Food Defense Plan Quick Check (FDPQC) inspection protocols data
    • potentially receive establishment type, industry code, and season start/end month fields via Firm Search results

Release 14.0 – Sample Enhancements and Training Courses (February 2023)

  • ORAPP – Regulatory partners can:
    • copy or download information about all individual Sample Number / Analysis type (PAF) / Problem Assignment Code (PAC) results submitted in a single Excel file
    • submit multiple Sample Collections, with different Sample Numbers, in a single Excel file
    • submit multiple Sample Receipt and Analysis results, with different Sample Numbers, in a single Excel file
    • submit results for multiple Sample Numbers / PAF and/or PAC in a Sample Collection or Sample Analysis Excel file
    • leverage the new e-Learning courses about Sample Collections

Release 13.0 –Sample Enhancements and Training Courses (September 2022)

  • ORAPP – Regulatory partners can:
    • submit multiple files simultaneously for Sample Collection, Sample Receipt, or Sample Analysis (all files must be of the same type)
    • view status message and email confirming that a new Program Assignment Code (PAC) and/or Problem Area Flag (PAF) was added to their Sample Collection
    • leverage the new e-Learning courses about Firm Search, Firm History, and Non-Contracted Inspections (NCI)