Device Registration and Listing | FDA
2024年10月7日 · Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
How to Register and List | FDA
Registration and listing information is submitted by using FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM).
Establishment Registration & Device Listing - Food and Drug Administration
2025年1月6日 · You can enter a premarket submission number, a company name, registration or owner/operator number to search for registration and listing information. Learn More... Quick Search
Register a New Medical Device Facility: Step-by-Step Instructions
Once you have read the Registration Requirements page and are certain that you have enough time and information to complete a facility registration, click "Register my Facility" at the bottom...
Device Registration and Listing Module (DRLM): Step-by-Step …
Transfer Ownership of Devices or Facilities: Record an ownership transfer with the FDA, along with associated new owner information. Create Listings for Medical Devices: List your medical...
Registration and Listing - Food and Drug Administration
Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the...
Establishment Registration & Device Listing - Food and Drug Administration
2025年1月6日 · medical device manufacturers registered with FDA and medical devices listed with FDA Note: Registration of a device establishment, assignment of a registration number, or listing of a medical...
Clarifying US Medical Device Registration and Listing …
Discover the essential guidelines for US medical device registration and listing. Streamline the process with expert consulting to ensure FDA compliance.
DICE Initial Registration - Food and Drug Administration
Welcome to the FURLS Device Registration & Listing Module for Initial Registration U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) Division of Industry...