Becker Grand Rounds: Wally Pellerite June 30, 2011

FDA Organizational Structure 2 Office of the Commissioner Office of Foods Center for Food Safety & Applied Nutrition Center for Veterinary Medicine Center for Devices & Radiological Health Center for Drug Evaluation & Research National Center for Toxicological Research Center for Tobacco Products Center for Biologics Evaluation & Research Office of Chief Counsel Office of Women’s Health Office of Regulatory Affairs Office of External Affairs Office of Administrative Law Office of Policy, Planning and Budget Office of Legislation Office of the Chief of Staff Office of the Counselor to the Commissioner Office of Special Medical Programs Office of International Programs Office of the Chief Scientist Office of Administration Office of Equal Employment & Diversity Current as of June 9, 2011

Office of Regulatory Affairs 3 Office of Resource Management Office of Enforcement Office of Criminal Investigations Office of Regional Operations Regional Field Office, Central Region Regional Field Office, Northeast Region Regional Field Office, Pacific Region Regional Field Office, Southwest Region Regional Field Office, Southeast Region Current as of June 9, 2011

Center for Devices and Radiological Health 4 Office of the Center Director Office of Management Operations Office of Compliance Office of Device Evaluation Office of Science and Engineering Laboratories Office of Communication, Education, and Radiation Programs Office of Surveillance and Biometrics Office of In Vitro Diagnostic Device Evaluation and Safety CDRH Ombudsman Current as of June 8, 2011

Office of Compliance 5 Division of Enforcement A Division of Enforcement B Division of Risk Management Operations Division of Bioresearch Monitoring Cardiovascular Rhythm & Electrophys. Devices Special Investigations Program Enforcement A Regulatory Policy and Systems Field Operations Recall General Hospital Devices OB/GYN, Gastroenterology & Urology Devices Dental, ENT & Ophthalmic Devices General Surgery Devices Orthopedics and Physical Medicine & Anesthesiology Devices Program Enforcement B Radiology, Anesthesiology & Neurology Devices Vascular and Circulatory Support Devices Office of the Director Current as of June 8, 2011

CDRH Office of Compliance – Office of the Director 6 Director Steven Silverman Deputy Director for Medical Affairs Kimber Richter Deputy Director for Regulatory Affairs Larry Spears Quality Management System Staff Frances Benedict Program Management Staff Marguerite Jones(Acting) Promotion & Advertising Policy Staff Vacant Current as of June 8, 2011