The US Food & Drug Administration (FDA) has launched a new initiative to improve the safety of complex home-use medical devices such as hemodialysis systems, wound care and intravenous therapy devices. The agency is planning to start a ten-month pilot programme, beginning this summer, for manufacturers to submit labelling of home-use medical devices to a central website to improve access to information about the safe use of the devices for patients and caregivers. The FDA is also planning to implement measures to enhance post-market surveillance of home-use devices, using “HomeNet”, part of its Medical Device Surveillance Network adverse event reporting programme. In addition, the agency will develop guidelines for manufacturers in marketing home-use devices, conduct post-market surveillance and develop educational resources for patients and caregivers, according to massdevice.com. The guidelines for manufacturers will include suggestions to help them get pre-market approval or clearance, define the circumstances under which the agency might require that certain devices be labelled and recommend post-market surveillance to monitor and address adverse events in the home.

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