FDA user fee for 510(k) applications from 2008-2012
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 discount given to "small businesses" with less than US$100,000,000 in annual sales. Click here to download a PDF of FDA user fees.
FDA 510(k) APPLICATION FEE
Payable to the FDA to have them review a new 510(k) application.
2008 - $3404 ($1702)
2009 - $3693 ($1847)
2010 - $4007 ($2004)
2011 - $4348 ($2174)
2012 - $4717 ($2359)
FDA ESTABLISHMENT REGISTRATION FEE
Payable once per year by every registered medical device company.
2008 - $1706
2009 - $1851
2010 - $2008
2011 - $2179
2012 - $2364
No discount is provided to small businesses for the Establishment Registration fee.
Related services offered by Emergo Group:
- FDA 510(k) preparation and submission services
- US Agent representation to the FDA
- FDA GMP quality system implementation
