About FDA
Total Cost of the Process for the Review of Medical Device Applications
Back to Table of Contents: FY 2009 MDUFMA Financial Report
FDA uses data from time reporting surveys conducted during four 2-week periods each fiscal year to determine the percent of cost of each organizational component devoted to activities that is 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.
The following table presents the total costs for the review of medical device applications for FY 2008 and FY 2009, 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 1 year, and 96 percent within 2 years. Thus, obligations represent an accurate measure of costs.
FOOD AND DRUG ADMINISTRATION
PROCESS FOR THE REVIEW OF MEDICAL DEVICE APPLICATIONS
TOTAL COSTS BY COMPONENTS AND FUNDS
AS OF SEPTEMBER 30, 2009
Center for Devices and Radiological HealthFDA Organizational Component FY 2008 FY 2009 $179,941,933 $212,217,413 Center for Biologics Evaluation and Research $26,815,222 $29,121,473 Field Inspection and Investigation $11,835,564 $10,747,226 Agency General and Administrative Costs $16,606,880 $18,762,325 Total Process Costs $235,199,599 $270,848,437 Obligations from Appropriations $198,776,699 $223,545,693 Obligations from Medical Device User Fee Collections $36,422,900 $47,302,744
The costs for all but one component increased in FY 2009. The decrease in the area of Field Inspection and Investigation is attributed to the decline of the average cost of salary and benefits per Office of Regulatory Affairs FTE due to the hiring of a significant number of new entry-level field personnel in FY 2009. 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 2009.
FULL TIME EQUIVALENTS (FTES)
The table below presents FTE levels that support the medical device application review process by FDA organizational components. This is a measure of paid staff years devoted to device review. In FY 2009, FDA spent about 66 percent of its total funds for the salaries and benefits of the medical device process FTEs, and the balance of the funds went for support of these employees.
FOOD AND DRUG ADMINISTRATION
PROCESS FOR THE REVIEW OF MEDICAL DEVICE APPLICATIONS TOTAL FTES
AS OF SEPTEMBER 30, 2009
Organization \ Fiscal Year 2004 2005 2006 2007 2008 2009 Center for Devices and Radiological Health (CDRH) 713 794 765 806 843 853 Center for Biologics Evaluation and Research (CBER) 70 87 108 105 109 109 Office of Regulatory Affairs (ORA) 60 64 65 68 66 60 Office of the Commissioner (OC) 72 89 82 92 77 87 Total FTE 915 1,034 1,020 1,071 1,095 1,109
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