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Center for Devices and Radiological Health / Center for Biologics Evaluation and Research / Prescription Drug User Fee Act / Medical device / Indirect costs / Office of Regulatory Affairs / Cost / Premarket approval / Food and Drug Administration / Medicine / Health


APPENDIX E DEVELOPMENT OF COSTS FOR THE PROCESS FOR THE REVIEW OF MEDICAL DEVICE APPLICATIONS GENERAL METHODOLOGY The costs associated with the process for the review of medical device applications are based on
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Company

Arthur Andersen LLC / Shared Services / /

Currency

USD / /

Event

Reorganization / /

Facility

Laboratory Employees / FDA’s HQ / /

IndustryTerm

time-reporting systems / human drug applications / telecommunications / manufacturing facilities / device applications / finance / medical device applications / /

Organization

Legislation office of Policy / office of Communications / Outreach / and Development / Minority Health office of Women / Immediate Office / Division of Cost Determination Management / Women’s Health Office / office of Shared Services / office of Medical Products and Tobacco / office of Finance / Center for Devices and Radiological Health / National Center for Toxicological Research / office of Global Regulatory Operations and Policy / Commissioner Office / office of Regulatory Affairs / External Affairs Office / Center for Tobacco Products / Executive Secretariat Office / office of Foods / FDA / Policy and Planning Office / Food Safety / General Services Administration / Chief Counsel Office / Center for Drug Evaluation and Research / Department of Health and Human Services / Center for Veterinary Medicine / office of Shared Services FTE / office of the Secretary / Center for Biologics Evaluation and Research / office of Operations FY / office of Management / /

Position

Chief Scientist / Counselor / President / Commissioner / Agency General / Director of the Center / Secretary / /

Product

Olympus E-3 Digital Camera / /

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