Author

Marco Theobold

Director of Medical Device and Drug Services

Author

FDA Announces New Medical Device, Generic Drug, and Human Drug Compounding User Fees for FY 2020

Aug 8, 2019

The U.S. Food and Drug Administration (FDA) announced the new fee schedules for the Generic Drug User Fee Amendments (GDUFA) and the Medical Device User Fee Amendments (MDUFA) for the Fiscal Year (FY) of 2020. Additionally, FDA announced the new rates for human drug compounding outsourcing facilities. All of the new fees take effect October 1, 2019. These fees are a required part of FDA registration.

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) facilities named in an approved drug application on October 1, 2019. These fees are to be paid on October 1, 2019. The fees for foreign facilities are higher to compensate for the additional cost of inspections outside the United States. FDA also collects fees based on the number of approved Abbreviated New Drug Applications (ANDA) a facility holds and a one-time fee for new Type II Drug Master File submission. These funds are used to increase the speed of the delivery of generic drugs to the public and improve the predictability of the review process. FDA anticipates more ANDAs to be filed this year than last, causing a decrease in ANDA fees compared to 2019. This is likely welcome news after ANDA fees saw an increase of 17% from 2018 to 2019.

FY 2020 GDUFA Fees

Fee Class Rates for FY 2020
Facilities Domestic Foreign
Active Pharmaceutical Ingredient (API) $44,400 $59,400
Finished Dosage Form (FDF) $195,662 $210,662
Contract Manufacturing Organization (CMO) $65,221 $80,221
Applications
Abbreviated New Drug Application (ANDA) $176,237
Drug Master File (DMF) $57,795
ANDA Program Fees
Large (20 or more) $1,661,684
Medium (6-19) $664,674
Small (5 or less) $166,168

Human Drug Compounding Outsourcing Facility Fees

Facilities that compound human drugs and register as outsourcing facilities are exempt from certain sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act), but must pay an additional annual establishment fee and re-inspection fee if a re-inspection is required. Facilities with total sales of $1 million or less in the previous year may qualify for a reduced rate as a ‘small business’ as long as a small business reduction application was submitted by April 30, 2019 and approved by FDA.

FY 2020 Outsourcing Facility Fees

Fee Class Rates for FY 2020
Qualified Small Business Establishment $5,599
Non-Small Business Establishment $18,288
Re-inspection $16,798

Medical Device Establishment 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 2019, you must resubmit your information during renewal to FDA to remain qualified.

There is no fee deduction on establishment registrations for small businesses.  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 and is not paid just paid once for multiple establishments.  The fees have generally increased 7-9% from FY 2019, a larger jump than the 3-4% increase industry saw from 2018 to 2019.

FY 2020 MDUFA Fees

Fee Class Rates for FY 2020
Annual Establishment Registration $5,236
Applications Standard Small Business
Panel-Track Supplement $255,747 $63,937
De Novo Classification $102,299 $25,575
180-Day Supplements $51,149 $12,787
Real-Time Supplements $23,870 $5,968
510(k)s $11,594 $2,899
513(g) $4,603 $2,302
30-Day Notice $5,456 $2,728
PMA Annual Report $11,935 $2,984
PMA, PDP, PMR, BLA $340,995 $85,249

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, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

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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