The Food and Drug Administration (FDA) announced 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.
(CORRECTION: The docket remained open and accepted comments until November 13, 2015. The link for submitting comments is http://www.regulations.gov and docket # is: FDA-2015-N-2734.)
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10/13 Main Session and 1st Breakout
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