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Total Cost of the Process for the Review of Medical Device Applications in FY 2010

Back to Table of Contents: FY 2010 MDUFMA Financial Report

 

FDA uses data from time reporting surveys conducted during four two-week periods each fiscal year to determine the percent of cost of each organizational component devoted to activities included in the process for the review of device applications, as defined in MDUFMA. See Appendix D for the descriptions of the allowable activities and Appendix E for more detail on how FDA develops the costs of the process for the review of medical device applications.   
 
Table 6 presents the total costs for the review of medical device applications for FY 2009 and FY 2010, by FDA organizational components and by source of funds (appropriations and user fee collections).  The amounts are based upon obligations recorded as of the end of each fiscal year. In the past, over 81 percent of obligated funds in FDA were expended within one year, and 96 percent within two years. Thus, obligations represent an accurate measure of costs.
 
Table 6
Process for the Review of Medical Device Applications

Total Costs by Components and Funds

As of September 30, 2010

 

FY 2009
FY 2010
Center for Devices and Radiological Health
 $ 212,217,413
 $ 224,106,088
Center for Biologics Evaluation and Research
 $   29,121,473
 $   30,132,907
Field Inspection and Investigation
 $   10,747,226
 $   13,893,434
Agency General and Administrative Costs
 $   18,762,325
 $   24,575,111
Total Process Costs
$270,848,437
$292,707,540
Obligations from Appropriations
$223,545,693
$235,520,440
Obligations from Medical Device User Fee Collections
$47,302,744
$57,187,100

 The costs for all components increased in FY 2010. The overall increase reflects both the increase in costs for pay and support for other areas, and an increase in the total number of FTEs devoted to the process for the review of medical devices in FY 2010. 

  
  
Full Time Equivalents (FTEs)
 
Table 7 presents FTE levels that support the medical device application review process by FDA organizational component.  This is a measure of paid staff years devoted to device review.  In FY 2010, FDA spent about 55 percent of its total funds for the salaries and benefits of the medical device review process FTEs, and the balance of the funds went for support of these employees.
 
Table 7
Process for the Review of Medical Device Applications
Total FTEs
    As of September 30, 2010
 
 
FTE Used Each Year
Organization  \  Fiscal Year
2004
2005
2006
2007
2008
2009
2010
Center for Devices and Radiological Health (CDRH)
713
794
765
806
843
853
949
Center for Biologics Evaluation and Research (CBER)
70
87
108
105
109
109
120
Office of Regulatory Affairs (ORA)
60
64
65
68
66
60
72
Office of the Commissioner (OC)
72
89
82
92
77
87
89
Total FTE
915
1,034
1,020
1,071
1,095
1,109
1,230
 
FTE numbers in table 7 show CDRH, CBER, and ORA staff transferred to the consolidated shared-services organization in OC as if they were still in CDRH, CBER, and ORA. 
 
In FY 2010 the medical device program experienced its largest increase in FTEs since FY 2005. The CDRH FTEs increased by 11 percent (853 to 949) in FY 2010 while the CBER FTE showed a 12 percent increase (109 to 120).
 
In addition to the FTE numbers shown in table 7, CDRH also expended 77 more contractor staff-years on the medical device review process in FY 2010 than it did in FY 2002. 

 

Next Section: Management Challenges for FY 2011