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

  • ORAPP – Regulatory partners can:
    • search FDA inventory for firms located in any state to streamline obtaining FDA Establishment Identifier (FEI) numbers for sample collection submissions
    • 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
      • access the public Training Overview page
      • access the private Training page containing e-Learning courses
    • access the updated Contact Us page
  • System-to-System, ORAPP, and Enhanced DX Client – Regulatory partners can:
    • submit sample collection data while providing the firm name and address as optional data fields instead of providing an FDA Establishment Identifier (FEI) number
    • update previously submitted sample collection 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)

Release 11.1 –Firm Search, Sample, and Content Management Enhancements (April 2022)

  • System-to-System – Regulatory partners can:
    • receive a Firm’s Points of Contact (POCs) list along with Contact POC identifiers
    • submit or update Contracted Inspection results with any proposed changes to the Firm POCs list, using Contact POC identifiers
  • ORAPP – Regulatory partners can:
    • view the street address, city, state, zip code, and county as separate fields in Firm Search
    • view a new Technical Onboarding page for resources to onboard System-to-System users
    • view an updated About page with additional outreach resources about ORA DX program
  • System-to-System, ORAPP, and Enhanced DX Client – Regulatory partners can:
    • be prevented from using an incorrect state laboratory ID for sample submission
    • access an additional list of values (LOVs) for Pesticides (PES) and Radionuclides (NUC) analysis types

Release 11.0 – Inventory Reconciliation and Firm Search Enhancements (January 2022)

  • ORAPP – Regulatory partners can:
    • submit firm inventory for automated matching with the FDA firm inventory
    • sort on any field in the Firm Search query results tabular display
    • view new, additional firm history data elements (not previously available in ORAPP) related to consumer complaints, inspections, investigations, Corrective Action Reports (CAR), and registrations
    • learn more about ORA DX inspection and firm inventory data sharing capabilities on new publicly available overview pages