FDA expands use of vital sign monitors to enable remote care, modifications during COVID-19 emergen…

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. Examples of this would include monitoring for COVID-19 itself or for co-existing conditions, as well as hardware and software modifications that increase remote monitoring capability. In addition, the expanded use extends to some software products that pair with the monitors and use algorithms to provide clinical decision support (CDS) insights.

The applicable connected non-invasive monitors listed in the emergency guidance are: clinical electronic thermometers, ECGs, cardiac monitors, ECG software for over-the-counter use, pulse oximeters, respiratory rate or breathing frequency monitors, non-invasive blood pressure monitors and electronic stethoscopes.