Author

Marco Theobold

Director of Medical Device and Drug Services

FDA Announces New Medical Device and Generic Drug User Fees for FY 2022

Aug 5, 2021

The U.S. Food and Drug Administration (FDA) has announced the Fiscal Year (FY) 2022 fees under the Generic Drug User Fee Amendments (GDUFA) and the Medical Device User Fee Amendments (MDUFA).

The fiscal year begins October 1st, 2021 and ends September 30th, 2022. Drug and device facilities must pay the fees to maintain a compliant FDA status.

Drug Facility Fees

Under GDUFA, FDA assesses and collects fees from Active Pharmaceutical Ingredient (API) facilities, Finished Dosage Form (FDF) facilities, and Contract Manufacturing Organization (CMO). Fees for facilities outside of the US are higher to compensate for the additional cost of inspection.

GDUFA facility fees increased for FY 2022, reversing the fee reduction seen from 2020 to 2021. Domestic and foreign API fees have increased by about 2 percent. FDF and CMO fees increased both in the U.S. and abroad by about 5 percent. Contrarily, businesses of all sizes saw about a 0.4 percent reduction in program fees.

The increase in facility fees could have stemmed from a final year adjustment, which allows FDA to increase fees to provide for up to 3 months of operating reserves. The reserves will offset costs associated with projected human generic drug activities at the beginning of FY 2023. To determine the adjustment, FDA analyzed projected collections and obligations and considered the financial burden increased fees might place on the industry. Ultimately, FDA decided to increase fees to provide for 7 weeks of operating reserves.

FY 2022 GDUFA Fees

Fee Type FY 2021 FY 2022
Facility Fees Domestic Foreign Domestic Foreign
Active Pharmaceutical Ingredient (API) $41,671 $56,671 $42,557 $57,557
Finished Dosage Form (FDF) $184,022 $199,022 $195,012 $210,012
Contract Manufacturing Organization (CMO) $61,341 $76,341 $65,004 $80,004
GDUFA Program Fees – Based upon the number of approved ANDAs held
Large (20 or more ANDAs) $1,542,993 $1,536,856
Medium (6 – 19 ANDAs) $617,197 $614,742
Small (5 or fewer ANDAs) $154,299 $153,686
Application Fees
ANDA $196,868 $225,712
Type II DMF $69,921 $74,952

Medical Device Fees

FDA requires fees for certain medical device applications, periodic reporting on class III devices, and for the annual registration of establishments. Businesses with total sales of less than $100 million for the most recent tax year can qualify as a small business for a reduced fee on applications. Businesses with total sales of less than $30 million can receive a waiver of first premarket applications or reports. If you qualified for a reduced or waived fee in FY 2021, you must resubmit your information during renewal to FDA to remain qualified.

Small businesses do not receive a fee deduction for establishment registrations. The establishment registration is the same for businesses of all sizes and FDA will not consider a registration complete until it is paid. Additionally, this fee applies to every physical location that a company owns that handles certain functions on medical devices.  Each physical location is required to pay the establishment registration fee. For FY 2022, medical device fees increase by about 2.5 percent from FY 2021. FDA suggests this is to account for inflation over the last year.

FY 2022 MDUFA Fees

Fee Type 2021 2022
Annual Establishment Registration $5,546 $5,672
Application Fees Standard Small Business Standard Small Business
510(k) $12,432 $3,108 $12,745 $3,186
513(g) $4,936 $2,468 $5,061 $2,530
De Novo Classification $109,697 $27,424 $112,457 $28,114
PMA, PDP, PMR, BLA $365,657 $91,414 $374,858 $93,714
panel-track supplement $274,243 $68,561 $281,143 $70,286
180-day supplement $54,849 $13,712 $56,229 $14,057
real-time supplement $25,596 $6,399 $26,240 $6,560
BLA efficacy supplement $365,657 $91,414 $374,858 $93,714
PMA annual report $12,798 $3,200 $13,120 $3,280

Registrar Corp is a private company that assists businesses in complying with FDA regulations. We can help to determine what fees your facility is subject to and facilitate payment to FDA. For more information, call us at +1-757-224-0177, email us at info@registrarcorp.com or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livechat.

Author


Marco Theobold

Director of Medical Device and Drug Services

A highly regarded expert in medical device and drug regulations by the U.S. Food & Drug Administration (FDA), Marco brings a unique perspective for medical device and drug companies seeking to distribute products in the United States. He proudly provides guidance on FDA regulations for pharmaceutical, medical device, and radiation emitting device (RED) companies.

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