Meeting the Statutory Conditions for User Fees in FY 2009
MDUFMA imposes three statutory conditions that FDA must satisfy before it can collect
and spend user fees. FDA’s calculations show that FDA met these conditions in
FY 2009. See summaries set forth below.
The first condition is a funding condition that affects FDA’s fee collections in FY 2009.
MDUFMA, as amended, specifies a minimum amount that must be appropriated for the
Device and Radiological Health line of FDA’s appropriation, exclusive of user fees, for
each year. For FY 2009, that minimum amount is $241,881,000 (rounded to the next
whole thousand dollars). In FY 2009, the final appropriation for the Device and
Radiological Health line of FDA’s appropriation, exclusive of user fees, was
$280,587,000. Therefore, FDA met the first condition.
The second condition is that the amount of user fees collected by FDA in each fiscal
year must be specifically stated in the Appropriation Acts. The President signed the
FY 2009 Omnibus Appropriation Act, Public Law 111-8, on March 11, 2009. It states
that the amount collectable from medical device user fees is $52,547,000. Therefore,
FDA met the second condition.
The third condition is that user fees may only be retained and spent in years when FDA
also spends a specified minimum level of appropriated funds, exclusive of user fees, for
the review of medical device applications. The minimum level is the appropriations that
FDA spent on the process for the review of medical device applications in FY 2002,
multiplied by an adjustment factor. That adjusted minimum level for FY 2009 is
$140,709,031. FDA obligated $223,545,693 from appropriations in FY 2009 on the
process for the review of device applications as defined in MDUFMA. Because FDA
spent more than the specified minimum level, FDA met the third condition.
MDUFMA also contains a provision that FDA obligations for medical device
establishment inspections must be equal to or greater than it spent in FY 2002, increased
by 5 percent each fiscal year. If FDA does not satisfy this condition for 2 consecutive
years, FDA is not allowed to use accredited third-parties to conduct certain medical
device establishment inspections in the future years. FDA spending on medical device
establishment inspections exceeded the specified minimum level for each of the most
recent 2 fiscal years, so FDA may continue to permit accredited third-parties to conduct
certain medical device establishment inspections in future years.
Additional details on the calculations that show FDA satisfied these statutory conditions
are provided in Appendix A.