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Total Costs of the Process for the Review of Medical Device Applications in FY 2011

Back to Table of Contents: FY 2011 MDUFMA Financial Report

Table 7 shows the costs for the review of medical device applications during the past two fiscal years by FDA organizational component.  It depicts the full cost of the process for the review of medical device applications paid from appropriations and user fees.  The amounts are based upon obligations recorded at the end of FY 2011.

 

Table 7

Process for the Review of Medical Device Applications --Total Cost

As of September 30, 2011

 

FDA COMPONENTFY 2010FY 2011
Center for Devices and Radiological Health (CDRH)$224,106,088$225,023,130
Center for Biologics Evaluation and Research (CBER)$30,132,907$33,715,375
Field Inspection and Investigation (ORA)$13,893,434

$14,464,887

Agency General and Administrative Costs (HQ)$24,575,111$20,549,656
TOTAL PROCESS COSTS$292,707,540$293,753,048
Obligations from Appropriations$235,520,440$234,496,548
Obligations from Medical Device User Fees$57,187,100$59,256,500

Numbers may not add due to rounding to the nearest dollar.

 

Of the total $293,753,048 obligated in FY 2011 in support of the process for the review of medical device applications as defined in MDUFMA, about 20 percent came from MDUFMA user fees and about 80 percent came from appropriations.

 

In FY 2011 the costs for all components increased slightly except for HQ, which saw a significant decrease.  This decrease in resources expended by HQ for the process for the review of medical device applications can be directly linked to the overall decrease in spending by HQ (FDA wide).

The development of the costs associated with the process for the review of medical device applications is described in more detail in Appendix E.

 

Next Section: Management Challenges for FY 2012