美国FDA公布医疗器械产品2022年年费标准：The enterprise shall conduct annual registration for fiscal year 2022 within the annual registration time range from October 1 to December 31, 2021.
All establishments that are required to register, must pay the annual registration user fee using the Device Facility User Fee (DFUF) system. After paying the annual registration user fee and obtaining the Payment Identification and Confirmation Numbers (PIN/PCN), the annual registration must be completed using the FDA Unified Registration and Listing System (FURLS)/Device Registration and Listing Module (DRLM.). The annual registration user fee for FY 2022 is $5,672. The Federal Register (FR) Notice announcing the fee can be found at: https://www.federalregister.gov/documents/2021/08/02/2021-16408/medical-device-user-fee-rates-for-fiscal-year-2022.
You must pay the annual registration user fee and complete the annual registration (a two-step process) using two different systems. Both steps must be completed for your establishment to be considered registered for FY 2022