FDA revises user fees for 2008-2012

The US Food and Drug Administration (FDA) has made significant changes to the Medical Device User Fee and Modernization Act (MDUFMA II). This Act establishes the fees manufacturers, reprocessors and specification developers will pay for 510(k) application reviews, 513(g) submissions, Premarket Approvals, Establishment Registration and more for the period 2008 through 2012. The fees have been significantly changed and are effective as of 1 October 2007.

Fee for 510k applications reduced
The fee for new FDA 510(k) submissions will be $3404 in 2008. Previously, the fee was $4158.

Small businesses now receive a 50% discount and non-US companies can also qualify
Small businesses with less than US$100 million in sales will pay $1702 for 510(k) submissions and receive a 50% discount for most other fees as well. Previously, companies only qualified for the small business discount if they filed a US federal tax return. Most foreign companies do not file a tax return with the US Internal Revenue Service so they could not qualify for the discount. Under the new plan, the FDA will allow foreign small businesses to submit proof of sales and certification from their national taxing authority. The company's Chief Financial Officer will then have to certify those documents and send that information to the FDA. More details on this will be published soon.

New fee for Establishment Registration
Although many user fees for submissions have been reduced, the big surprise for manufacturers is a new annual Establishment Registration fee. This fee will be US$1706 in 2008 and will rise gradually to $2364 in 2012. There is no discount on this fee for small businesses. It is unclear how and when this fee will be levied to the 13000 device companies already registered, but the FDA is expected to release more details on this soon. There are also additional new fees that will apply to many companies.

Reduced review times for 510k submissions
With passage of the revised user fee structure, the FDA will now review 90% of 510(k) submissions within 90 days and 98% within 150 days.

With these changes, the FDA will eventually get up to 23% of its funding from user fees. We have only covered a few of the many fees the FDA charges. However, we have created a simple chart that shows the FDA fees and you can view it here.

Regards,

Evangeline Loh, PhD, RAC
Director of Regulatory Affairs
Emergo Group, Inc.

P.S. For more detailed information on the Medical Device User Fee and Modernization Act II, please visit the FDA website at http://www.fda.gov/cdrh/mdufma/