FDA plans to hold a meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee on June 2 and 3, 2016, to discuss and make recommendations concerning the infections associated with heater-cooler devices. The The FDA is seeking expert recommendations to provide to health care providers and health facilities to help mitigate risks to patients. This meeting will be announced in the Federal Register to provide further details.
The Circulatory System Devices Panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational devices for use in the circulatory and vascular systems and makes appropriate recommendations to the Commissioner of Food and Drugs.
Acting Designated Federal Officer (DFO)
Evella F. Washington