Cost of preparing and submitting a FDA 510k application plus FDA fees
Emergo Group has prepared more than 100 FDA 510(k) applications so we are very familiar with what the FDA wants to see in each application and what pitfalls to avoid. The FDA does not provide a 510(k) template to follow and that is why many people find them very difficult to complete properly.
This is also why many consultants will charge an hourly rate to complete 510(k) applications, leaving you with the uncertainty of how much it will ultimately cost. Again, because we have completed so many applications, we are able offer you a FIXED PRICE to prepare and submit your 510(k) application to the US Food and Drug Administration. Our price includes unlimited phone and email service during the preparation of your application.
The FDA also charges fees to review your 510(k) application.
Shown below are the user fees the FDA charges to review 510(k) applications. An annual fee for Establishment Registration is also charged to all companies. The number in (brackets) is the discount given to "small businesses" with less than US$100,000,000 in annual sales. The fiscal year for the FDA starts on October 1 and ends September 30 each year. All prices in USD.
FDA 510(k) APPLICATION FEE
Payable to the FDA to have them review a new 510(k) application.
2009 - $3693 ($1847) - The 2009 fiscal year starts October 1, 2008
2010 - $4007 ($2004)
2011 - $4348 ($2174)
2012 - $4717 ($2359)
FDA ESTABLISHMENT REGISTRATION FEE
Payable once per year by every registered medical device company.
2009 - $1851
2010 - $2008
2011 - $2179
2012 - $2364
No discount is provided to small businesses for the Establishment Registration fee. Click here to download a one page PDF that shows all FDA user fees.
Please contact us for a free proposal.
Other services we offer:
FDA medical device 510(k) process chart
FDA quality and regulatory compliance outsourcing
All medical device quality management and regualtory consulting services
