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FDA Issues Draft Guidance For Physiologic Closed-Loop Control Devices

 
• By Brian Bossetta

The US agency’s draft document highlights technical considerations to enhance safety and efficacy for the development of medical devices employing physiologic closed-loop control technology. PCLC tech can benefit health care providers by lessening their workloads.

FDA entrance sign 2016

The US Food and Drug Administration has issued draft guidance intended to promote consistency in reviewing medical device submissions to the agency that incorporate physiologic closed-loop control (PCLC) technology.

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