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  • Import Trade Auxiliary Communications System
    WARNING: This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes all devices storage media attached to this system This system is provided for Government-authorized use only Unauthorized or improper use of this system is prohibited and may result in
  • FDA Industry Systems
    FDA Industry Systems (FIS) was created to facilitate making submissions to the U S Food and Drug Administration (FDA), including registrations, listings, and other notifications
  • Import Trade Auxiliary Communications System
    Welcome to Import Trade Auxiliary Communications System Scheduled maintenance may cause ITACS outages from March 30 2026 2030 ET to March 30 2026 2330 ET WARNING: This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which
  • FDA Industry Systems - PRA
    The burden time for this collection of information is estimated to average 30 minutes per response, including the time to review instructions, search existing data sources, gather and maintain the data needed, and complete and review the collection of information Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing
  • Cancel, Deactivate, or Reactivate a Facility Registration
    Cancel, Deactivate, or Reactivate a Facility Registration May, 2025 The process of cancelling or deactivating a registration takes less than five minutes The process of reactivating a registration takes approximately 20 minutes and is very similar to registering a facility for the first time Be sure that you allow enough time to complete the process in one sitting, as partially completed
  • Add Replace Proprietary Names or Importers to Listings
    Add Replace Proprietary Names from Active Listings by File Upload - Multiple Listings After selecting this option, you will see the Upload File screen From this screen, you may download a sample Excel spreadsheet to your local drive and upload it with the listing number (s) and proprietary names of your medical devices
  • OCARUserGuide - U. S. Food and Drug Administration
    Observations and Corrective Action Report Corrective Action Report Center for Food Safety and Applied Nutrition U S Food and Drug Administration Online Account Administration FDA’s Unified Registration and Listing System FDA Industry Systems Office of Regulatory Affairs FDA Establishment Identification Food Safety Modernization Act Industry
  • CDER OMQ e-Portal FURLS User Guide
    FDA’s Unified Registration and Listing System (FURLS) FURLS is a specific component of FIS Persons with an FDA account ID and password for the FIS electronic portal can use the FURLS systems to exchange information with the Agency
  • Device Registration and Listing Module System
    Your session has expired Please try login using your user id and password
  • Device Registration and Listing Module (DRLM): Step-by-Step Instructions
    Device Registration and Listing Module (DRLM): Step-by-Step Instructions May, 2025 Index of Help Files Getting Started Register a New Medical Device Facility Change Registration Information for a Facility Transfer Ownership of a Facility (Report Purchase) Create Listings for Medical Devices View Your Registration and Listing Information Cancel, Deactivate, or Reactivate a Facility Registration





中文字典-英文字典  2005-2009