The USFDA is a scientific, regulatory and public health agency. The FDA’s Center for Devices and Radiological Health (CDRH) establishes reasonable assurance of safety and effectiveness of new medical devices before they are marketed in the United States while ensuring devices currently in the market remain safe and effective. CDRH’s regulatory paradigm is risk management throughout the total product life cycle of the device. The use of valid scientific evidence, decisions based on the best information and knowledge available, least burdensome means for industry and a serious attempt to make product development more predictable and less costly will speed the time to market from a design concept to a viable product that is safe and effective. FDA is interested in the critical path of bringing innovative products to the public faster because of the significant benefit to the public. The Center routinely consults with experts in academia, industry, community and other government agencies. The collaborative relationship helps speed innovation in medical device technology, in which many of these devices are first of a kind. As the development of new technologies proceed at a rapid pace, FDA will continue to face challenges to resolve complex issues associated with emerging technologies including breakthrough devices using nanotechnology, robotics, new sensors, devices to meet special needs of our aging population for prosthetics, remote monitoring, and home health care.
Carole Carey is currently the Director of FDA’s Center for Devices and Radiological Health (CDRH) International Affairs Staff. Prior to her present position, she was a senior scientific reviewer of cardiovascular devices. She was awarded a two-year Fellowship under the State Department’s Mansfield Program from 2003-2005, and spent the second year training side-by-side with her technical counterparts in Japan’s Ministry of Health, Labour, and Welfare (MHLW). She received her Bachelor in Electrical Engineering at Johns Hopkins University and a Masters degree in Engineering at Loyola College in Baltimore, MD. She is a Senior Member of IEEE. In her present capacity, she functions as an international regulatory and technical advisor, conducts regulatory workshops to foreign government officials and organizations, participates in global harmonization efforts and continues to serve as liaison in international device standards development.