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.)
- Discussion Paper
- Date, Time and Location
- Federal Register Notice
- Webcast
- Agenda
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- Contact Us
FDA Campus Information (Airports, Directions, Lodging Accommodations, Public Transportation, etc.)
Webcast
10/13 – Main Session and 1st Breakout
10/13 – 2nd Breakout
10/14 – Main Session and 1st Breakout
10/14 – 2nd Breakout
Susan Monahan.
[email protected].
Allison Kumar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Rm 5402, Silver Spring, MD 20993-0002, 301-796-6369, email: [email protected]