The FDA is seeking feedback on the design and development of devices that deliver life-saving therapies in critical-care environments.
The issue — physiological closed-loop controlled devices used to deliver anesthesia, vasoactive drugs and fluids and mechanical ventilation — will be the focus of an Oct. 13-14 workshop at the agency’s White Oak campus in Silver Spring, Md.
“Recent advances in medical device technology and control system science have increased the development of PCLC medical devices,” according to an Aug. 17 Federal Register notice announcing the meeting. “This may or may not introduce new risks to patients, but could introduce new medical device hazards that, considered during device design and development, can be mitigated throughout the device life-cycle.”
PCLC devices help clinicians and patients by automatically making adjustments to therapeutic delivery — something that could prove highly beneficial during mass casualty events, for example.
Potential areas of discussion slated for workshop include:
The deadline to submit comments on all aspects of the workshop is Sept. 1.