The Medical Device User Fee Amendments (MDUFA) and the Generic Drug User Fee Amendments (GDUFA) were reauthorized on August 18, 2017 to be in effect through September 30, 2022. The U.S. Food and Drug Administration (FDA) recently published the Fiscal Year (FY) 2018 fees for both MDUFA and GDUFA, introducing new types of fees and changes in rates from FY 2017. All MDUFA and GDUFA fees begin on October 1, 2017. To prepare medical device and drug businesses for these requirements, Registrar Corp outlines some notable changes to these amendments this year.
Fees for medical device establishments:
MDUFA requires a user fee from medical device establishments that register with FDA, as well as fees for certain applications, notifications, and other types of submissions filed on or after October 1, 2017. Small businesses, defined for this regulation as having less than $100 million in gross sales during the most recent tax year, are eligible for reduced rates on most fees. All other facilities are subject to a standard fee. Some significant changes to MDUFA for this fiscal year are explained below.
Annual Establishment Registration – All medical device establishments that are required to register with FDA must pay the Annual Establishment Registration user fee. The fee for this year is $4,624 (a $1,242 increase from FY 2017). Unlike with other MDUFA fees, there is no waiver or reduction for small businesses.
510(k) Application – The standard fee for 510(k) applications sees an increase of $5,876 from the FY 2017 rate of $4,690 to $10,566. Small businesses are required to pay $2642, facing an increase of $297 from the previous year.
De Novo Classification Application – New to the recent reauthorization of MDUFA is a fee for De Novo Classification applications. A standard business that files an application following the start of FY 2018 is required to pay $93,229, while a small business pays $23,307.
Refer to the chart below for a detailed comparison of MDUFA’s fee changes between FY 2017 and FY 2018.
FY 2018 MDUFA Fees
|Annual Establishment Registration||$3,382||$4,624|
|Application Fees||Standard||Small Business||Standard||Small Business|
|De Novo Classification||N/A||N/A||$93,229||$23,307|
|PMA, PDP, PMR, BLA||$234,495||$58,624||$310,764||$77,691|
|BLA efficacy supplement||$234,495||$58,624||$310,764||$77,691|
|PMA annual report||$8,207||$2,052||$10,877||$2,719|
Fees for drug establishments:
GDUFA requires user fees for certain drug establishments producing active pharmaceutical ingredients (API) or finished dosage forms (FDF), the submission of certain drug master files (DMF) for generic drug products, and the submission of certain applications for generic human drug products. New additions to GDUFA include abbreviated new drug application (ANDA) program fees and contract manufacturing organization (CMO) facility fees. Some significant changes to GDUFA for this fiscal year are explained below.
Contract Manufacturing Organization Fees – For the recent GDUFA reauthorization, CMO facility fees apply to FDF facilities that are identified in at least one approved ANDA, but are not the ANDA holder or an owner or affiliate of the holder. These fees are a two-thirds reduction of FDF facility fees for qualifying establishments. Domestic CMOs are required to pay a user fee of $70,362, while foreign CMOs pay $85,362.
ANDA User Fees – The user fee for the submission of a single abbreviated new drug application (ANDA) has increased from $70,480 to $171,823.
ANDA Program Fees – Businesses holding ANDAs are now required to pay a user fee in relation to how many they hold. The smallest ANDA program, with as little as one approved ANDA, begins with a user fee of $159,079. A business holding between six and nineteen approved ANDAs is required to pay a medium program fee of $636,317. The largest program fee for businesses holding twenty or more approved ANDAs is $1,590,792.
Refer to the chart below for a detailed comparison of GDUFA’s fee changes between FY 2017 and FY 2018.
FY 2018 GDUFA Fees
|ANDA Program Fees – Based upon the number of approved ANDAs held|
|Large (20 or more ANDAs)||N/A||$1,590,792|
|Medium (6 – 19 ANDAs)||N/A||$636,317|
|Small (5 or fewer ANDAs)||N/A||$159,079|
|Type II DMF||$51,140||$47,829|
Not sure which user fees you may be subject to? Registrar Corp’s Regulatory Specialists can help determine your relevant fees and facilitate payment with FDA. Call us at +1-757-224-0177, or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.