FDA User Fees for 510(k) Applications

Shown below are the user fees the FDA charges to review 510(k) applications. A new annual fee for Establishment Registration will also be charged to all companies. All prices in USD. The number in (brackets) is the price paid by "small businesses" with less than US$100,000,000 in annual sales.

FDA 510(k) Application Review Fee

Payable to the FDA to have them review a new 510(k) application. Pricing effective until September 30 each year.

2009 - $3693 ($1847)
2010 - $4007 ($2004)
2011 - $4348 ($2174)
2012 - $4049 ($2024)

FDA Establishment Registration Fee

Payable once per year by every registered medical device company.

2009 - $1851
2010 - $2008
2011 - $2179
2012 - $2029

No discount is provided to small businesses for the Establishment Registration fee.