The FDA's Outlook for Quality in Device Manufacturing

Timothy Ulatowski
Director, Office of Compliance
Center for Devices and Radiological Health
U.S. Food & Drug Administration

Topics to be discussed:

• Global harmonization of quality standards, the industry and regulator partnership
• Building quality into a device remains elusive for a segment of the industry
• The current enforcement statistics provide mixed signals about medical device quality
• FDA initiatives to improve public health through quality manufacturing
• Challenges to achieving device quality
• Outlook on the quality horizon from a regulator's perspective

Timothy A. Ulatowski is the Director, Office of Compliance, Center for Devices and Radiological Health. He manages four divisions tasked with promoting consumer health and safety, promoting product quality, and enforcing the medical device and radiological health laws and regulations. Mr. Ulatowski has been with FDA since 1974, and with the Office of Compliance since January 2003.

Prior to his recent appointment he was Director, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices. He served as the U.S. government representative for Study Group 1 (Premarket) of the Global Harmonization Task Force and on several cross-cutting FDA committees dealing with such topics as reuse of single use devices, user fee implementation, and international standards implementation.

Mr. Ulatowski holds a B.S. degree in Microbiology with honors from the Pennsylvania State University with additional undergraduate study in engineering and computer science, and an M.S. degree in Biomedical Engineering from Georgetown University School of Medicine in consortium with Catholic University, Department of Engineering.