- 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
- www. access. fda. gov
www access fda gov
- www. access. fda. gov
www access fda gov
- 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
- 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
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