Medical Device User Fee Rates for Fiscal Year 2018

Medical Device User Fee Rates for Fiscal Year 2018

The US FDA announced Medical Device User Fee Rates for Fiscal Year 2018 on Monday morning (August 28, 2017). The  Medical Device User Fee Rates for Fiscal Year 2018 will impact the annual registration fee along with a number of submissions. For FY18, the registration fee for each establishment is $4,631 (in U.S. Dollars). All establishments that are involved in the production and distribution of medical devices intended for use in the United States are required to pay the establishment registration fee.The full set of fees for FY 18 are below.

Readers familiar with fees from past years will note a significant increase in many areas from FY 2017. For example, the FY 17 registration fee was $3,382. The FY 18 registration fee increased by $1,249. That is not the only Medical Device User Fee Rates for Fiscal Year 2018 to increase, the  standard 510(k) fee nearly doubled with an increase of $5,582. This is the fee to have the most dramatic increase. Such an increase will place a significant emphasis on the small business waiver which requires an annual tax return.

 

Also, a new fee makes the list – a DeNovo submission fee. The De Novo fee will help provide more staff time to ensure the De Novo review can be completed in a reasonable time. The De Novo submission is nowhere near as common as a 510(k), but the nearly $70,000 in savings will place huge importance on qualifying for the small business fee.

 

FY18 User Fees for Medical Device Applications
The following table identifies the FY18 User Fees for Applications (in US Dollars)

application type

standard fee

small business fee

510(k)‡

10,542

2,636

513(g)

4,186

2,093

De Novo classification

93,017

23,254

PMA, PDP, PMR, BLA

310,058

77,515

panel-track supplement

232,544

58,156

180-day supplement

46,509

11,627

real-time supplement

21,704

5,426

BLA efficacy supplement

310,058

77,515

annual report

10,852

2,713

30-day notice

4,961

2,481

†  For small businesses with an approved SBD.
‡  Note: all types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee.  However, there is no user fee for 510(k)s submitted to the FDA by an FDA-accredited third-party reviewer
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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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