function checkform() { FDA IMPORTER. If you have any changes to your listings, return to the main menu and select Change, Cancel or Reactivate Listings to update your listing information. Log into FURLS using the owner/operator account id and password. The .gov means it’s official.Federal government websites often end in .gov or .mil. The person designated by the owner/ operator of an establishment responsible for the annual registration of the establishment and the device listing. If you have existing registrations, you will be asked to confirm that the establishment being registered does not already appear in the list that is displayed. Create and update all of the official correspondents’ FURLS accounts, including their own account(s), Assign official correspondents to registrations, Make changes, updates and cancellations to registrations and listings that they created, View registration and listing information for the establishments that they created, View all non-exempt listings belonging to the owner/operator that must be replaced. Division of Industry and Consumer Education (DICE) Instructions for . All establishments required to register must first visit the Device Facility User Fee website to pay the user fee. How to Study and Market Your Device, Recalls, Market Withdrawals and Safety Alerts, Important Reminders about Registration and Listing, FDA Onsite Registration and Listing Verifications, Frequently Asked Questions about the New Device Registration and Listing Requirements, Device Advice: Comprehensive Regulatory Assistance, registration and listing information must be submitted electronically, CDRH Learn with Device Registration and Listing, CDRH Learn Course: Paying the Annual Registration User Fee via the Device Facility User Fee (DFUF) Website, CDRH Learn Course: FURLS Device Registration and Listing Module for Initial Registration, CDRH Learn Course: FURLS Device Registration and Listing Module for Annual Registration  (PDF - 811KB). Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. if (document.theform.item14.value == "") {window.alert("Please supply a brief summary. The Food and Drug Administration Amendments Act (FDAAA) of 2007 requires that all registration and listing information (Annual, Initial or Updates) be submitted electronically unless FDA grants a waiver. Device Registration and Listing, Recalls, Market Withdrawals and Safety Alerts, Important Reminders about Registration and Listing, FDA Onsite Registration and Listing Verifications, Frequently Asked Questions about the New Device Registration and Listing Requirements, Device Advice: Comprehensive Regulatory Assistance, Downloading your listing information from FURLS, Reactivating or Deactivating a Registration, Reactivating or Deactivating a Device Listing, Updating Owner/Operator and Official Correspondent Account Information, Updating Registration and Listing Information, FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM), submitted your registration and listing information electronically, and. ", Select the box next to the new official correspondent and click on "Continue.". FDA Shipper (As shown on Customs document, BOL or airway bill) Company Name Address City State/Province Zip/Postal Code Country … FURLS Device Registration & Listing Initial Registration U.S. Food and Drug Administration Center for Devices and Radiological Health Division of Industry and Consumer Education (DICE) Instructions for Foreign, Existing Registrations in Account . Below table provide you a brief description of FDA requirements for each product categories. Minutes. Please try login using your user id and password. [CDATA[> A device listing can only be reactivated for an establishment that has an active registration. Division of Industry and Consumer Education (DICE) Instructions for . You can either choose from the owner/operator’s existing listings or, if not found in the existing listings, you can create a new listing for your device. 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