Author

Marco Theobold

Director of Medical Device and Drug Services

FDA Announces New Medical Device User Fees for FY 2023

Oct 7, 2022

The U.S. Food and Drug Administration (FDA) has announced the Fiscal Year (FY) 2023 fees under the Medical Device User Fee Amendments (MDUFA). 

The fiscal year begins October 1st, 2022 and ends September 30th, 2023. Medical device facilities must pay the fees to maintain a compliant FDA status. 

Medical Device Fees 

FDA requires fees for medical device establishments covering:  

  • Certain medical device applications 
  • Periodic reporting on class III devices 
  • 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 2022, you must resubmit your information during renewal to FDA to remain qualified. 

Establishment registrations are consistent across all business sizes and must be paid to complete registrations. For the establishment registration fee, there are no waivers or reductions for small establishments, businesses, or groups. Companies must pay the establishment registration fee for each physical location that a company owns that handles certain functions on medical devices. 

For FY 2023, all medical device fees increased from FY 2022. FDA suggests this is to account for inflation over the last year. 

FY 2023 MDUFA Fees 

Fee Type 2022 2023
Annual Establishment Registration $5,546 $6,493
Application Fees Standard Small Business Standard Small Business
510(k) $12,745 $3,186 $19,870 $4,967
513(g) $5,061 $2,530 $5,961 $2,980
De Novo Classification $112,457 $28,114 $441,547 $110,387
PMA, PDP, PMR, BLA $374,858 $93,714 $132,464 $33,116
panel-track supplement $281,143 $70,286 $353,238 $88,309
180-day supplement $56,229 $14,057 $66,232 $16,558
real-time supplement $26,240 $6,560 $30,908 $7,727
BLA efficacy supplement $374,858 $93,714 $441,547 $110,387
PMA annual report $13,120 $3,280 $15,454 $3,864

FDA will not consider medical device registrations to be complete unless all required payments have been remitted. If FDA has not received your payments by the December 31st deadline, your establishment may be removed from FDA’s database, rendering your registration invalid. Registrar Corp can help you determine what fees your facility is subject to and facilitate payment to FDA.  

Get assistance with FDA compliance.

Registrar Corp’s Regulatory Specialists can help you comply with FDA’s medical device regulations.

For more assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day: www.registrarcorp.com/livechat.

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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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