Total Costs of the Process for the Review of Medical Device Applications in FY 2011
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.
Process for the Review of Medical Device Applications --Total Cost
As of September 30, 2011
FDA COMPONENT FY 2010 FY 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 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.