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How do I register my business with the FDA? Go to FURLS at access.fda.gov/oaa/. 1 Enter the premarket submission number.
Registration and listing provide the FDA with the location of medical device establishments and the devices manufactured at those establishments
Who needs FDA establishment Registration? 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. This process is known as establishment registration (Title 21 CFR Part 807).
If you have not yet paid your annual registration user fee, you must visit the FDA User Fee website and pay for each registered facility prior to completing U.S. Agent Input Screen Select Product Activities Enter Proprietary Name(s)
How do I update my FDA establishment Registration? Log into the FDA Industry Systems (FIS). Choose “FURLS Food Facility Registration Module (FFRM)” from the list of available systems on Account Management Home Page. Choose the “Update Facility Registration” option from the FFR main menu.
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