发布时间：2020-12-04 01:03:57 阅读量：592
All medical device establishments, that are required to register, must pay the annual registration user fee, using the Device Facility User Fee (DFUF) website, and complete their annual establishment registration via the FDA Unified Registration and Listing System (FURLS)/Device Registration and Listing Module (DRLM) by December 31st of each year.
If the official correspondent completed the annual registration for the establishment on or after Saturday, October 24, 2020, please disregard this e-mail.
If the establishment is no longer required to register, the official correspondent should log into FURLS/DRLM and deactivate the establishment's registration.
For assistance with navigating the website to pay the annual registration user fee, please contact the User Fee Helpdesk by email at email@example.com.
For assistance with completing the annual registration, deactivating a registration, or resetting the FURLS password, please send an email to the CDRH Registration and Listing Helpdesk at firstname.lastname@example.org. A new FURLS account should not be created if you have an existing FURLS account. The official correspondent must use their existing FURLS account to access the establishment's registration record.
All United States (U.S.) Agents must create a FURLS account if they do not have an existing FURLS account to confirm that they are the United States (U.S.) Agent for a foreign establishment. Each U.S. Agent will receive an email that notifies her/him of the need to confirm that she/he agrees to act in this capacity for your registered establishment. The email will provide instructions on how to access and confirm the information in FURLS/DRLM. If she/he fails to confirm, then FDA will inform the establishment's Official Correspondent that a new U.S. Agent must be identified. Failure to provide valid U.S. Agent information will result in the deactivation of the registration. Carefully review this section for accuracy and make any needed corrections before you submit the annual registration for the establishment. Please consider notifying the U.S. Agent of this verification process, so she/he is prepared to act in response to the email by FDA.