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  • 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
  • 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
  • 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
  • PNSI - access. fda. gov
    PNSI - access fda gov PNSI
  • Device Registration and Listing Module System
    Your session has expired Please try login using your user id and password
  • Create a Medical Device Certificate to Foreign Government (CFG) Application
    Create a CFG Application Log into the FDA Industry Systems (FIS) https: www access fda gov and select "CDRH Export Certification Application Tracking System" from the list of systems available on the FURLS Home Page as shown in Figure 1 Figure 1: FDA Industry Systems Page
  • FECV - FURLS Export Certificate Validator
    This Portal allows validation of export certificates issued by the Food and Drug Administration CVM eCATS (CVM Export Certification Application and Tracking System) issued by the Center for Veterinary Medicine Search CVM-Issued Export Certificates
  • www. access. fda. gov
    www access fda gov
  • Search, Clone, or Modify an Application
    Validating CDRH-Issued Export Certificate Print Electronic Certificate or Approval Letter When the Exports Team has approved issuance of the requested document, you will receive an “Export Certificate Application Approved” or “EPL Application Approval” email notification with instructions on how to access the document
  • Register a New Medical Device Facility: Step-by-Step Instructions
    If you believe your device is exempt from FDA premarket notification requirements leave the Premarket Submission Number blank If your device is part of a combination product that includes a drug or biologic, check the box





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