AUTOLOGOUS CELL PROCESSING DEVICE COMPONENTS' REGULATORY STATUS WEIGHED BY FDA; REGULATION OF CELL PROCESSING AT HEALTH FACILITIES ALSO UNRESOLVED
This article was originally published in The Gray Sheet
Executive Summary
FDA is considering whether use of devices in autologous cell processing and treatment would "establish a new use" for products approved for other indications, Susan Alpert, director of the agency's Office of Device Evaluation, said at a Nov. 17 FDA workshop in Gaithersburg, Maryland.