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KCI is First to Commit to FDA Medical Device Home Use Labeling
Jun 3, 2010
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Kinetic Concepts, Inc. became the first manufacturer to commit to submitting labeling for its products used in the home to the Food and Drug Administration as part of the agency’s medical device Home Use Initiative. KCI will voluntarily submit labeling for its products cleared by FDA for home use for inclusion in the home use device labeling repository on the FDA’s website.

As home-based care becomes more prevalent and sophisticated, the FDA is stepping up efforts to ensure complex medical devices have the safeguards needed for safe home use by patients. The FDA is launching a 10-month pilot program in the summer of 2010 enabling manufacturers of home use devices to voluntarily submit their labeling for posting on a central website repository. The repository will provide a central location for home care patients and caregivers to access important information about the safe use of their devices.

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