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Home-Use Device Guidance Outlines Design, Labeling Considerations

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.

Pre-market submissions for devices intended to be used in the home should describe the manufacturer's efforts to take into account unique environmental considerations and other factors that could impact safety and effectiveness, according to an FDA draft guidance released Dec. 12.

Relevant environmental considerations include specific intended use locations, such as urban/suburban residential or office/car locations, according to the document, titled...

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