FDA to Fund Device Registry in 2011
BY LAUREN UZDIENSKI, FEBRUARY 9, 2010
As outlined in President Obama's proposed budget for the 2011 fiscal year, the FDA has increased their operating budget for the upcoming year by about 23% to $4 billion. The agency has said the bulk of the increase will be put to use hiring 1,000 new staff members and revamping the food safety division, a top priority for the Obama administration.
The CDRH will receive $326 million in funding, $4 million of which will be dedicated to creating a medical device registry. The registry will be designed by the FDA and link unique device identifiers to electronic health data.
The agency is also budgeting for an additional $59 million in user fees in 2011, up from about $53 million in 2010. As FDA News reports (subscription only), this increase is partially due to increased inspection fees. Manufacturing facilities inspected by the FDA will now have to pay the "full cost of re-inspections and associated follow-up work" in the case of GMP or other violations.
