Full article reprinted from "The Gray Sheet"- February 8, 2009
The Obama administration's fiscal year 2011 budget request includes $4 million for a new medical device registry that would link unique device identifiers to electronic health data. The registry would be designed and built by FDA. Read more...
Obama Budget Request Would Fund National Device Registry At FDA
Full article reprinted from "The Gray Sheet"- February , 2009
The Obama administration's fiscal year 2011 budget request includes $4 million for a new medical device registry that would link unique device identifiers to electronic health data. The registry would be designed and built by FDA.
FDA budget documents, released Feb. 1 as part of the 2011 federal budget request, call for investments in four broad categories: food safety, patient protections, regulatory science and tobacco oversight.
The national device registry would receive $2.3 million under the "advancing regulatory science" initiative and $1.7 million under the "protecting patients" initiative.
FDA's device center would receive $325.7 million in federal funding under the budget request - up $10.3 million, or 3%, from the fiscal 2010 appropriations level.
In addition, CDRH would receive $59 million in user fees, up 11.5%, raising the center's total funding by 4% to $384.8 million.
The budget request would fund 65 new hires at the center.
For FDA as a whole, President Obama calls for $2.5 billion in federal funds, up 6%. Including user fees, the total FDA budget would be $4 billion, up 23% from FY 2010 total FDA appropriations.
House FDA Appropriations Subcommittee Chair Rosa DeLauro, D-Conn., commended Obama's proposal, but advocacy group Alliance for a Stronger FDA said the 6% increase would not offset the impact of "a decade of neglect."
The Alliance wants some $349 million more in federal funds for FDA than Obama proposed, including $59 million more than was requested for CDRH.
Device trade group AdvaMed agreed the center could use more funding, "but in this budget environment, just getting an increase was a positive," said Senior Executive VP David Nexon.
- Jessica Bylander
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