FDA www.fda.gov will conduct a public workshop on October 13-14, 2015 at the FDA White Oak Campus in Maryland. The workshop entitled “Physiological Closed-Loop Controlled (PCLC) Devices” will discuss the challenges related to the design, development, and evaluation of critical PCLC devices.
FDA considers PCLC devices to be an emerging technology to be used in critical care environments such as in intensive care and emergency medicine settings. Such devices include closed-loop anesthetic delivery, closed-loop vasoactive drug and fluid delivery, and closed-loop mechanical ventilation.
For example, a closed-loop oxygen delivery device may be able to automatically adjust the fraction of inspired oxygen when an individual’s oxygen saturation level drifts too high or too low. PCLC devices could also help patients and practitioners by automating a number of tasks that might include adjusting mechanical ventilation, to deliver anesthesia, and for fluid resuscitation.
The discussions at the workshop will include benefit-risk considerations, design strategies, pre-clinical testing, and making clinical evaluations for specific product areas of PCLC medical devices. Ideas generated during this workshop may initiate developing new draft guidance and/or standards for PCLC medical devices.
The workshop attendees will include people from industry, academia, medical societies, patient groups, standard bodies, and other relevant stakeholders. Participants may also include scientists and engineers developing PCLC medical devices as well as end users including physicians, nurses, and patients.
For further details on the public workshop, go to the August 17, 2015 issue of the Federal Register at www.gpo.gov, page 49248.