This session will focus on items, usually mechanical in nature, that play a role in development, processing and administration of blood products and cellular therapies. Designation of a product as a biologic vs. a medical device has been of critical importance to a sponsor – the device route has been much less burdensome. The speakers – who have R&D, manufacturing and regulatory experience - will address the current regulatory requirements for medical devices and combination products involving blood and cellular therapies and comment on changes likely to occur in the system in the near future. They will describe some of the hurdles confronting manufacturers, researchers and developers in the blood and cell therapy fields. Case studies will be presented to illustrate concepts and stimulate interactive discussion. There will be substantive advice and discussion on submitting a request for product jurisdiction.