CDRH Learn Course: FURLS Device Registration and Listing Module for Annual Registration (PDF - 811KB).The ‘Remove’ button will remove the currently selected item the device window and. To remove the device(s) click on the ‘Remove Devices’ button. CDRH Learn Course: FURLS Device Registration and Listing Module for Initial Registration To remove a device it must be added into the device window any number of devices can be specified within this window although they all must have a unique Vendor ID and Product ID combinations.CDRH Learn Course: Paying the Annual Registration User Fee via the Device Facility User Fee (DFUF) Website.Email: CDRH Learn with Device Registration and Listing.Email: assistance with policy or detention issues, please contact the Registration and Listing Staff at:.Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.įor assistance with registration and listing status, please contact the CDRH Registration and Listing Help Desk at: Registration and listing provide the FDA with the location of medical device establishments and the devices manufactured at those establishments. If a device requires a premarket submission before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), De Novo, PMA, PDP, HDE).Īll registration and listing information must be submitted electronically, unless a waiver has been granted. Generally, establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices.
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