The User Fee programs help the Food and Drug Administration (FDA) to fulfill its mission of protecting public health and accelerating innovation in the industry. The Office of Financial Management (OFM) is responsible for the financial management of the user fee programs. OFM maintains an accounts receivable system used for user fee invoicing, collections, reporting, and data maintenance.
FDA FY2022 User Fee Table
Below are the lists of the user fee amounts FDA will collect in FY2022 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices, and outsourcing facilities.
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.
GDUFA enables FDA to assess industry user fees to bring greater predictability and timeliness to the review of generic drug applications. Congress enacted GDUFA to ensure patients have access to safe, high-quality, and affordable generic drugs.2
Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect fees for biosimilar biological products from October 2017 through September 2022. BPD fees are assessed for products in FDA’s BPD program. BPD fees include the initial BPD fee, the annual BPD fee, and the reactivation fee.
Outsourcing facilities fees, is defined in section 503B(d)(4) of the FD&C Act, are facilities that meet all of the conditions described in section 503B, including registering with the FDA as an outsourcing facility and paying an annual establishment fee.
Device user fees were first established in 2002 by the Medical Device User Fee and Modernization Act (MDUFMA). Under the user fee system, medical device companies pay fees to the FDA when they register their establishments and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S. and for certain other types of submissions. These fees help the FDA increase the efficiency of regulatory processes with a goal of reducing the time it takes to bring safe and effective medical devices to the U.S. market.
Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business.
For questions, please contact the User Fee Helpdesk at (301) 796-7200 or email@example.com.