Meeting the Legal Conditions for User Fees in FY 2011
MDUFMA imposes three legal conditions that FDA must satisfy for the Agency to be able to collect and spend medical device user fees. A summary of how each of these legal conditions was satisfied in FY 2011 is shown below. Detailed explanations and calculations are described in Appendix A.
The first legal condition: The Device and Radiological Health line of FDA’s Salaries and Expenses appropriation (excluding user fees) must be a minimum of $250,264,000 (rounded to the nearest thousand dollars), which reflects the adjustments that apply to FY 2011. In FY 2011, the final appropriation for the Device and Radiological Health line of FDA’s Salaries and Expenses appropriation (excluding user fees) was $322,370,000. Therefore, the first legal condition was satisfied.
The second legal condition: The amount of user fees collected for each fiscal year must be specified in that year’s appropriations acts. The President signed the FY 2011 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (Title II of Public Law 112-10, the “Department of Defense and Full-Year Continuing Appropriations Act, 2011”) on April 15, 2011. It specified that $61,860,000 shall be derived from medical device user fees. Therefore, the second legal condition was satisfied.
The third legal condition: User fees may be collected and used only in the fiscal years when FDA spends a specified minimum amount of appropriated funds for the review of medical device applications. This specified minimum is the amount FDA spent on the review of medical device applications from appropriations (exclusive of user fees) in FY 2002, multiplied by an adjustment factor. That specified minimum level for FY 2011 is $145,586,000 (rounded to the nearest thousand dollars). In FY 2011, FDA obligated $234,496,548 from appropriations (exclusive of user fees) for the review of medical device applications. Because FDA spent more than the specified minimum amount from appropriations in FY 2011, the third legal condition was satisfied.
MDUFMA also provides that FDA obligations for medical device establishment inspections must be equal to or greater than the amount spent in FY 2002, increased by five percent each fiscal year. If this condition is not met for two consecutive years, FDA is not allowed to use accredited third parties to conduct certain medical device establishment inspections in future years. Because spending on medical device establishment inspections exceeded the specified minimum level for each of the most recent two fiscal years, FDA may continue to permit accredited third parties to conduct certain medical device establishment inspections in future years.