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)