Two New “Medical Device Registration And Listing” Tutorials On CDRH Learn
The Food and Drug Administration (FDA) is pleased to announce two new CDRH Learn tutorials to help users navigate and complete their medical device annual registration and listing. Medical device establishments are required to re-register and pay a registration fee annually. Re-registration and payment of the fee must be completed by Dec. 31, 2013.
Each web-based tutorial is short—fewer than 30 minutes long—and provides step-by-step instructions with images. The first tutorial provides instructions on how to pay the fee through the Device Facility User Fee (DFUF) website . The second tutorial provides instructions on how to complete the annual registration through the FDA's Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM).
For assistance with paying the annual registration user fee, please contact the User Fee Helpdesk by phone at 301-796-7200 or by email at firstname.lastname@example.org.
For assistance with completing the annual registration and listing process, please contact the FDA’s Center for Devices and Radiological Health (CDRH) Registration and Listing Helpdesk by phone at 301-796-7400 or by email at email@example.com.
Food and Drug Administration
Center for Devices and Radiological Health