FDA Public Workshop - Physiological Closed-Loop Controlled Devices

The Food and Drug Administration (FDA) has held a public Workshop entitled "Physiological Closed-Loop Controlled (PCLC) Devices." The topic discussed was challenges related to the design, development, and evaluation of critical care PCLC devices. FDA considers PCLC devices an emerging technology and held a workshop focusing on design, development and performance evaluation of PCLC systems intended for use in critical care environments. Such devices included closed-loop anesthetic delivery, closed-loop vasoactive drug and fluid delivery, and closed-loop mechanical ventilation.

Workshop agenda, a discussion paper, presentation slides and workshop webcast are available at the workshop web page: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm457581.htm