MobiHealth News March 20, 2020
The temporary policy also extends to some clinical decision support software used in conjuction with these remote monitor devices.
The FDA announced today a new policy that permits expanded use of connected, non-invasive remote vital sign monitors until the end of the COVID-19 public health emergency.
The agency is relaxing its prior guidance so that healthcare teams can monitor their patients outside of the hospital with certain devices that were previously cleared by the FDA, thereby freeing up space for the high volume patients who are in need of care due to the novel coronavirus.
The agency said that it would “not intend to object to limited modification to the indications, claims, functionality or hardware or software” of these devices....
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