Device User Fee Fix Included In House-Passed Continuing Resolution

A continuing resolution bill approved by the House March 6 includes provisions that would permit FDA full access to medical device user fees at FY 2013 levels.

FDA would be able to draw on all of the medical device user fees paid by industry for FY 2013 under a provision in H.R. 933, a continuing resolution appropriations bill approved by the House March 6. The last continuing resolution approved by Congress, scheduled to sunset on March 27, limited FDA spending to 2012 levels, thereby denying the agency access to the full funds industry provides for medical device reviews and approvals. (See Also see "User Fee Limbo: FDA Will Not Have Access To Extra Industry Funds At FY 2013 Start" - Medtech Insight, 24 September, 2012..)

The current user fee agreement between industry and the FDA has been in place since last summer, but ensuring that all the user fees the industry contributes to FDA can be accessed by the agency has been a thorny challenge over the last few months as Congress

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