Originally Published MDDI January 2003
Many advanced devices, first cleared by CDRH for use by trained caregivers, are also used by laypeople under prescription. Unintended side effects, such as death and injuries, are an ever-present risk. But FDA believes that home-use of the devices poses added hazards. To improve the safety of home-use devices, CDRH plans to form an advisory committee to address the issue. Representatives of agencies that deal with such devices will meet with consumers to discuss the risks of home use. CDRH will use the resulting information in planning policies for use of devices in the home environment. The action was prompted by the results of a public meeting held in September 2002.
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