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Final Home-Use Device Guidance Expected Mostly ‘As Is’ By Year’s End

Representatives of home health care and device companies, hospital staff, home health care professionals, device standard-setting groups and consultants put together a draft priority list of challenges and solutions for home-use devices at an Association for the Advancement of Medical Instrumentation summit meeting earlier this month, anticipating finalized FDA guidance by the end of the year.

A final FDA guidance on home-use devices, only slightly changed from an earlier draft, is expected by the end of the year. In the meantime, companies should take the lead in issuing clearer “instructions for use” documents for medical equipment employed in the home, experts said at an AAMI-sponsored summit on devices in nonclinical settings earlier this month.

Attendees – who represented the home health care industry; device manufacturers; hospital staff, including nurses and biomedical engineers; home healthcare professionals; and device standard-setting groups and consultants – put together...

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