USA – FDA issues draft guidance on assessing physiologic closed-loop control devices

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) in late December issued a draft guidance on developing medical devices with physiologic closed-loop control (PCLC) technology to ensure their safe and effective use. Submissions should carefully weigh patient and device-related risks as well as use-related hazards.

These devices consist of a sensor that measures a physiologic variable from the patient, a controller/control algorithm, and an actuator that delivers, or removes, energy or an article such as a drug to the patient.

FDA says these devices, which provide automated therapy delivery to patients for fluid resuscitation, ventilation, and anesthesia, are “emerging applications for the critical and emergency care environments.” Some examples of PCLC devices include hemodynamic stability controllers and mechanical ventilation and oxygenation controllers…