Latest Medical Device User Fee Amendment (2022)

FDA has released the new medical device user fee amendment (MDUFA) for 2022.

 

The US Food and Drugs Administration has established a 2.5% increase in Fees charged to Medical Devices manufacturers. This fee increase includes applications for Premarket Approval, 510(k) clearance, establishment registration and other applications in the US market.  

 

The increment takes effect from the beginning of FDA’s 2022 fiscal year (FY 2022) from October 1, 2021 to September 30 2022. However, Premarket approval applications have to be submitted before September 30, 2021. 

 

How does this latest MDUFA affect small businesses? 

FDA continues to discount certain fees for small businesses. Small businesses in this case being businesses with sales under $100 million annually. 

 

While there are waivers and fee reduction of other types of fees for small businesses, there is none for establishment registrations. Establishment registration is the same for all applicants, regardless of the size of the business. 

 

Establishment registration for FY 2022 is $5,672 across the board. 

 

Standard and small Business Application Fees for FY 2022

 

Application Types	Standard Fees	Small Business Fees
510(k)	$12,745	$3,186
513(g)	$5,061	$2,530
Premarket Approval	$374,858	$93,714
De Novo	$112,457	$28,114
Panel-track Supplement	$281,143	$70,286
180-Day Supplement	$56,229	$14,057
Real-Time Supplement	$26,240	$6,560
BLA Efficacy Supplement	$374,858	$93,714
30-Day Notice	$5,998	$2,999
PMA Annual Reporting on a Class III device	$13,120	$3,280

 

How does FY 2022 compare to FY 2021? 

Compared to the 2021 fiscal year which saw a fee increase of 7% from the previous year, the 2022 plan is much more agreeable. With the exception of the annual establishment registration fee which was $5,546 across board, here are the fees for the concluding FY 2021. 

 

Standard and small Business Application Fees for FY 2021

 

Application Type	Standard Fee	Small Business Fee
510(k)	$12,432	$3,108
513(g)	$4,936	$2,468
PMA	$365,657	$91,414
De Novo	$109,697	$27,424
Panel-track Supplement	$274,243	$68,561
180-Day Supplement	$54,849	$13,712
Real-Time Supplement	$25,596	$6,399
BLA Efficacy Supplement	$365,657	$91,414
30-Day Notice	$5,851	$2,926
PMA Annual Reporting on a Class III device	$12,798	$3,200

 

Cosmereg is a regulatory firm that assists medical device producers in their efforts to remain compliant with FDA regulations. Whether annual fees or one-time payments, we will guide you through it all. You can call us at +1 727 3509380 for more information.