FY 2010 Medical Devices Appropriation
During FY 2010, FDA used funding for the Device Review process in the following ways:
- Conducting a review of the 510 (k) program and reviewing the internal and public comments
- Expanding expertise in the Review of Medical Device Applications (including Software Review Experts)
- Focusing on Meeting Device Review Goals
- Increasing Core Competency Training for Reviewers
- Developing and utilizing new document reports to help managers better manage review case loads. These reports would provide managers with upcoming due dates for applications to reduce the number of applications that miss decision timeframes unnecessarily
Appropriated Increases were devoted to the following:
- Import Safety: including capacity building, with education of foreign countries and support of FDA foreign offices
- Increase capacity to address pediatric premarket and postmarket issues and improve children's health nationwide (Pediatric Champion)
- Increase CDRH's capacity to regulate the diagnostic technology used to develop drugs and dosing based on an individual's genetic make-up (Personalized Medicine)
- Develop high-priority guidance relating to devices & global initiatives (New Regs. Writers in OCD)
- Reserve Request: although Congress did not appropriate increases for the review, FDA requested and received additional funds from the MDUFA Reserve fund to hire additional reviewers. These funds were approved late in the fiscal year and not completely spent in FY 2010. FDA will re-request these funds to bolster the Premarket Device review effort. Expanding expertise in the Review of Device Applications , focus on meeting MDUFA review goals.
FY 2011 Appropriations Update
Continuing Resolution (CR)
- FDA is operating under a Continuing Resolution (CR) through December 3 unless Congress passes an FY 2011 budget appropriation bill before then.
- There is no guarantee that Congress will pass an appropriation bill by December 3
CR Impact on Use Fees
- FDA will collect user fees at the legislatively mandated FY 2011 level; however, the current CR authorizes FDA to spend user fee dollars at the FY 2010 level only.
- FDA will not spend past FY 2010 authorized levels – until Congress passes a new appropriation authorizes the Agency to do so.
- The authorized FY 2010 spending level is $57,014,000.
- The legislatively mandated FY 2011 collections level is $61,860,000.
- The difference between FY 2010 and FY 2011 is $4,846,000