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  Medical Device User Fees for Fiscal Year 2018

2018 medical products FDA fees

FDA announced in the United States local time on August 28, 2017 2018 fiscal year (October 1, 2017, September 30, 2018) FDA service charges case, 2017 years on August 29 FDA corrected part of the Charge amount.

FDA2018 annual rate higher than the 2017 fiscal year,

FDA annual certification fee from the original USD3,382 upgrade to USD4,624, an increase of 37%;

FDA510K audit fee standard rate from the original USD4,690 increased to USD10,566, more than doubled.

Important Information on Medical Device User Fees for Fiscal Year 2018

(For FDA 2018 fiscal year: October 1, 2017 to September 30, 2018)

Major rates:

project
 2018 fiscal year (2017.10.01-2018.09.30)
 
2018 fiscal year medical device company registration annual certification fee
 USD4,624 manufacturers (no relief)
 
2018 fiscal year FDA510 (K) audit fee (each 510K application)
 USD 10,566 (standard charge)

USD 2,642 (FDA certified for small business qualified companies to enjoy the preferential charges)
 

* FDA Small Business Qualification refers to the company's total tax revenue or sales of more than 100 million US dollars, and need 1-2 months in advance to apply for FDA small business qualification to enjoy the benefits;

Small Business: This is defined as having gross receipts or sales of no more than $ 100 million for the most recent tax year.

FY2018 User Fees for Medical Device Applications
The following table identifies the FY18 User Fees for Applications (in US Dollars)

?  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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