Technical Considerations for Medical Devices With Physiologic Closed-Loop Control Technology; Guidance for Industry and Food and Drug Administration Staff; Availability
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Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology." Physiologic closed-loop control (PCLC) devices are intended for automatic control of a physiologic variable(s) through delivery of energy or substance using feedback from physiologic sensors. PCLC devices may play an important role in reducing cognitive overload, minimizing human error, and enhancing medical care during emergency response and medical surge situations. This guidance provides technical considerations for PCLC technology in order to promote development and availability of safe and effective PCLC medical devices.
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