OCD FY2004: Center for Devices and Radiological Health
The Center for Devices and Radiological Health (CDRH) is part of the U.S. Food and Drug Administration (FDA). CDRH promotes and protects the health of the public by ensuring the safety and effectiveness of medical devices as authorized by the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act and helps reduce unnecessary exposure to radiation from medical, occupational, and consumer products as authorized by the Radiation Control for Health and Safety Act of 1968. We achieve our mission by ensuring the health of the public throughout the "Total Product Life Cycle (TPLC)” of the products we regulate. Our TPLC vision embraces our commitment to focusing on all the stages in a product’s life, from development and design through obsolescence.
CDRH consists of six Offices:
- Office of the Center Director (OCD)
- Office of Communication, Education and Radiation Programs (OCER)
- Office of Compliance (OC)
- Office of Device Evaluation (ODE)
- Office of In Vitro Diagnostic Devices Evaluation and Safety (OIVD)
- Office of Management Operations (OMO)
- Office of Science and Engineering Laboratories (OSEL)
- Office of Surveillance and Biometrics (OSB)
Additional information about CDRH is available by calling 1-888-INFO-FDA or by visiting the CDRH website at www.FDA.Gov/CDRH.
Daniel G. Schultz, M.D.
Director, Center for Devices and Radiological Health
In July, acting FDA Commissioner Dr. Lester M. Crawford named Daniel G. Schultz, M.D., Director of the Center for Devices and Radiological Health (CDRH). Dr. Schultz joined FDA in 1994 as a medical officer in the General Surgery Branch of CDRH. During his career at FDA Dr. Schultz has been selected to various positions, including, chief medical officer in CDRH’s Division of Reproductive, Abdominal, and Radiological Devices (DRARD) in the Office of Device Evaluation (ODE), DRARD Division Director, ODE Deputy Director, and ODE Director.
A native of New York City, Dr. Schultz graduated from the City College of New York with a B.A. in political science. He received an M.D. from the University of Pittsburgh in 1974 and completed a combined internship in pediatrics and medicine at the University of New Mexico. In 1975, Dr. Schultz joined the Commissioned Corps of the U.S. Public Health Service. He served a three-year assignment as a general medical officer and clinical director of the Tuba City Indian Hospital on the Navajo reservation in Arizona and later completed a general surgical residency at the Public Health Service Hospital in San Francisco, California. In 1981, Dr. Schultz moved to Denver, where he did a fellowship in pediatric surgery and completed his general surgery training. Dr. Schultz is board certified in general surgery and family practice and is a Fellow of the American College of Surgeons.
Director, Office of Communication, Education and Radiation Programs
Ms. Lynne Rice was selected to serve as the Director of the Office of Communication, Education, and Radiation Programs (OCER) in March 2004. Ms. Rice has been employed by the U.S. Food and Drug Administration for over 24 years. She began her FDA career with the Bureau of Medical Devices, Office of Compliance in 1979, and joined the Division of Small Manufacturers Assistance (DSMA) in the Office of Training and Assistance in 1989 as a consumer safety officer. In 1996, Ms. Rice became the Deputy Division Director of DSMA, where she was responsible for directing staffing, budget, external affairs, consumer outreach, international activities, industry analysis, guidance development, oversight of Division websites and developing educational programs for newly proposed and final medical device regulations. In June 2002, Ms. Rice was selected as Deputy Office Director of the Office of Health and Industry Programs, OCER’s predecessor. Her leadership skills and outstanding ability to communicate CDRH’s message to our stakeholders as Deputy Office Director made her a natural selection for her role as Director of OCER.
In 1980, Ms. Rice received a B.A. in sociology and a B.S. in biology from Mt. St. Mary’s College, in Emmittsburg, Maryland. She is also a graduate of the Federal Executive Institute Leadership in a Democratic Society Program.
Dr. Donna-Bea Tillman, Ph.D.
Director, Office of Device Evaluation
In September, Dr. Donna-Bea Tillman became the Office of Device Evaluation Director. Dr. Tillman began her career in government with the Consumer Product Safety Commission, where she spent 3 years working to develop consensus standards for consumer products. In 1994, she joined ODE as a reviewer in the OB/Gyn Devices Branch, and in 1997, she was selected as the Branch Chief of DCRD’s Pacing and Neurological Devices Branch. In the fall of 2000, Dr. Tillman did a six-month fellowship on Capitol Hill in the Office of Congresswoman Louise Slaughter, where she was involved in legislation involving Medicare prescription drug reform and protection of private genetic information. Shortly after her return to FDA in 2001, Dr. Tillman was selected Deputy Director for the Division of Cardiovascular and Respiratory Devices of ODE and later Deputy Director of ODE for Technology and Review Policy. She provided a template for TPLC/MDUFMA recruitment and hiring teams, which has resulted in a tremendous infusion of new talent, not only for ODE but for all of CDRH.
Dr. Tillman earned a B.S.E. in Engineering from Tulane University in 1985, and a Ph.D. in Biomedical Engineering from the Johns Hopkins University in 1992.