Home-Use Meeting: Device Definition Should Include Wireless Products
This article was originally published in The Gray Sheet
Executive SummaryCDRH's efforts to better target its oversight for products principally used in patients' homes are raising fundamental regulatory questions like, "what is a medical device?
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Design of devices for home use should take into account the “large range of physical, sensory, cognitive and emotional capabilities and disabilities” home users may have, the FDA draft document recommends. Comments are due March 12.