Zdrowie i gospodarka · 17.08.2015
Physiological Closed-Loop Controlled Devices; Public Workshop; Request for Comments
The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Physiological Closed-Loop Controlled (PCLC) Devices." The topic to be discussed is challenges related to the design, development, and evaluation of critical care PCLC devices. FDA considers PCLC devices an emerging technology and aims to hold a workshop focusing on design, development and performance evaluation of PCLC systems intended for use in critical care environments. Such devices include closed-loop anesthetic delivery, closed-loop vasoactive drug and fluid delivery, and closed-loop mechanical ventilation. Dates and Times: The public workshop will be held on October 13 and 14, 2015, from 8 a.m. to 5 p.m. Location: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, Rm. 1503 (The Great Room), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http:/ /www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ucm241740.htm. Co