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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.
