Official announcement of FDA user fees 2022

FDA user fees 2022 for FDA small business application

Federal law authorizes the U.S. Food and Drug Administration (FDA) to collect FDA user fees 2022 for certain medical device submissions and establishment registration. On August 2, 2021, the FDA announced the FDA user fees 2022 in Medical Device User Fee Rates for Fiscal Year 2022. The FDA SBD certification user fees 2022 are required for the following types of medical device submissions:

• FDA premarket notifications (510(k)s)
• FDA premarket approval applications (PMAs)
• product development protocols (PDPs)
• De Novo classification requests
• some PMA and PDP supplements (for example, panel-track, 180-day, real-time, 30-day notice)
• premarket reports (PMRs)
• annual fee for periodic reporting on a class III device (PMAs, PDPs, and PMRs)
• requests for device classification information (513(g)s)
• original biologics license applications (BLAs) for certain medical devices reviewed by the FDA's Center for Biologics Evaluation and Research (CBER)
• BLA efficacy supplements

All of these discounts for when you obtain your SBD certification (FDA small business application)!

In addition, all medical device establishments are required to pay an annual establishment registration fee.

FDA 2022 User Fee for Establishment Registration

For FDA user fees 2022, the registration fee for each establishment is $5,672 (in United States dollars). There are no waivers or reductions for small establishments, businesses, or groups.

The annual establishment registration fee must be paid between October 1, 2021, and December 31, 2021. Obtain now your FDA small business application and designation!

Find below the FDA user fees 2022 for the FDA small business designation (FDA SBD certification) approved companies

Application Type

Standard Fee

Small Business (SBD) Fee†