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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

 

FDA Organizational ComponentFY 2008FY 2009

Center for Devices and Radiological Health

$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 Year200420052006200720082009
Center for Devices and Radiological Health (CDRH)713794765806843853
Center for Biologics Evaluation and Research (CBER)7087108105109109
Office of Regulatory Affairs (ORA)606465686660
Office of the Commissioner (OC)728982927787
Total FTE9151,0341,0201,0711,0951,109

 

Next Section:  Performance Goals