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Guidance for Home-Use Devices May Include Labeling Changes

November 17, 2010
Devicemakers that develop products designed for home use will likely see new labeling requirements as part of an upcoming guidance. The FDA may suggest devicemakers create different written instructions for the patient, prescriber of the device and the person training the consumer on how to use the device, Mary Weick-Brady, a senior policy analyst at CDRH, said. The enhanced labeling was suggested at a risk communication advisory committee meeting.
Devices & Diagnostics Letter