The US Food and Drug Administration should, as far as possible, rely on existing standards to achieve the objectives of its "home-use" initiative, which aims to assure the safe use of medical devices in patients' homes, says medtech industry association AdvaMed1.
The FDA had pointed out in a white paper published in April that the increasing use of devices by lay caregivers at home presented unique challenges in terms of caregivers’ knowledge, device usability (instructions for use, etc) and environment unpredictability (space limitations, electromagnetic interference, etc)2...
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