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

Release 14.0 – Sample Enhancements (January 2023)

  • ORAPP – Regulatory partners can:
    • submit multiple sample collections and /or PAF / PAC assignments in a single Excel file
    • submit sample receipts and analysis results for multiple sample numbers in a single Excel file
    • submit results for multiple sample numbers, analysis types (PAFs) and/or Program Assignment Codes (PACs) in a single Excel file
    • copy or download information about all individual sample number / PAF / PAC results submitted in a single Excel file

Release 13.0 – Firm Search, Sample, and Content Management Enhancements (September 2022)

  • ORAPP – Regulatory partners can:
    • submit multiple Excel files simultaneously for sample collection, sample receipt, or sample analysis (all files must be of the same type)
    • view a new status and email confirming that a new Program Assignment Code (PAC) and/or Problem Area Flag (PAF) was added to their Sample collection, when submitting a separate Excel file

Release 12.0 – Firm Search, Sample, and Content Management Enhancements (July 2022)

  • ORAPP – Regulatory partners can:
    • utilize enhanced FDA firm search for firms located in any state for sample collection submissions
      • Wildcard searches are automatically applied to the text entered in the Firm Legal Name, Doing Business As, and Address fields
    • view updated sample collection template instructions regarding the manufacturer’s expiration date
    • view additional instructions in the Status Summary column on the submission page
    • electronically submit all Program Assignment Code (PAC) and/or Problem Area Flag (PAF) using separate excel files for the same sample lab number
    • view new Training pages
      • Public Training Overview page
      • Private Training page containing e-Learning courses upon login to ORAPP
    • access the updated Contact Us page
  • System-to-System, ORAPP, and Enhanced DX Client – Regulatory partners can:
    • submit sample collection data using the firm name and address without providing an FDA Establishment Identifier (FEI) when the FEI number can be found based on the submitted firm name and address
    • update previously submitted sample analysis information
    • submit sample analysis results for all Program Assignment Codes (PAC) and/or Problem Area Flags (PAF) for a single FDA Sample Number using separate Excel files (ORAPP) or separate XML files (System-to-System, Enhanced DX Client)