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  4. Medical Device User Fee Amendments (MDUFA)
  5. Update on Medical Device Appropriations - FY 2010 Budget (July 27, 2009)
  1. Medical Device User Fee Amendments (MDUFA)

Update on Medical Device Appropriations - FY 2010 Budget (July 27, 2009)

  • Both the House and Senate FY 2010 Appropriation Bills for FDA match the increases in budget authority and existing user fee authority requested in the President's FY 2010 Budget.
  • For the total Device Program (CDRH and the Field), the FY 2010 funding level represents an increase of $34.7 M (or +12%) in budget authority over FY 2009.
    • This amount includes $4.9 M in Pay to support cost of living increases.
    • This amount also includes $29.9 M to support:
      • Safer Drug, Devices, and Biologics activities
      • Implementation of provisions of FDAAA
      • Strengthening science capacity in the areas of nanotechnology, genomics and personalized medicine.
  • The total FY 2010 Budget Authority request provides ongoing support for CDRH initiatives that include:
    • Critical Path
    • UDI
    • Increased Pediatric Device Availability
    • Action Plan for Import Safety (APIS)
  • The FY 2010 budget includes $57.0 M in total MDUFA user fee authority for the Agency. This FY 2010 authority level provides an additional $3.9 M for CDRH's medical device review program to support staff increases and ensure ongoing improvement in the review process.
  • Neither the House nor the Senate draft bills fund any of the proposed user fees in the President's FY 2010 Budget.
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