[UPDATE] FDA allows expanded use of certain health monitoring devices, to limit in-person patient–provider contact during the COVID-19 outbreak

The US FDA has issued guidance concerning the expanded use of certain, non-invasive health monitoring devices to facilitate remote patient monitoring while reducing patient–provider contact and exposure to the novel coronavirus, COVID-19.

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[UPDATE] FDA issues revised, expanded guidance on use of certain remote health monitoring devices during COVID-19

On 20 March 2020, in a bid to simultaneously enhance remote patient monitoring and limit face-to-face interactions between patients and healthcare providers, the US FDA published guidance concerning the expanded use of certain non-invasive, remote health monitoring devices – such as ECG monitors.

On 5 June 2020, the FDA issued new, revised guidelines concerning such remote health monitoring devices, which replace the earlier guidance and expand its scope to include additional device types and standards for consideration.

In the updated guidance, the FDA comments: “In the context of the COVID-19 public health emergency, the leveraging of current non-invasive patient monitoring technology will help eliminate unnecessary patient contact and ease the burden on hospitals, other health care facilities, and health care professionals that are experiencing increased demand due to the COVID-19 pandemic as it relates to diagnosis and treatment of patients with COVID-19 and ensuring other patients who require monitoring for conditions unrelated to COVID19 can be monitored outside of health care facilities.”

As per the initial guidance, the updated document maintains that the FDA may allow for modifications to the hardware of the specified devices if these will enhance their remote usability. Further, so long as they do not lead to unduly elevated risks, the FDA may allow amendments to approved device indications, claims or functionalities of the devices without prior submission of a premarket notification.

In the revised guidance, the FDA also recommends that the labels of specified devices be updated to include information that will help users better understand the device, such as Information on use conditions, in particular whether the device is intended for spot-checking, trend monitoring, or continuous monitoring, and a clear that recommendations provided by the device are purely supportive and should not be solely or primarily relied upon to prevent, diagnose, or treat COVID-19 or co-existing conditions.


Sources:

US FDA. Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised).
www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-non-invasive-remote-monitoring-devices-used-support-patient-monitoring-during
[Accessed 06/092020];
www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-5-2020


FDA allows expanded use of remote health monitoring devices, to limit in-person patient–provider contact during the COVID-19 outbreak

The outbreak of the novel coronavirus – COVID-19 – is a rapidly progressing public health emergency. In a bid to simultaneously enhance remote patient monitoring and limit face-to-face interactions between patients and healthcare providers, the US FDA has published guidance concerning the expanded use of certain non-invasive, remote health monitoring devices. The guidance has been issued with immediate effect, without prior public comment, and is to remain in place only as long as the outbreak remains a declared public health emergency.

In the guidance, the FDA explains: “FDA believes the policy set forth in this guidance will help address these urgent public health concerns by helping to expand the availability and capability of remote patient monitoring devices. Modified use of these devices may increase access to important patient physiological data without the need for in-clinic visits and facilitate patient management by health care providers while reducing the need for in-office or in-hospital services during the COVID-19 public health emergency.”

The guidance highlights various non-invasive health monitoring devices that can connect to wireless networks and transmit patients’ physiological health data directly to healthcare professionals – some devices can even apply algorithms to the data, which may help healthcare providers diagnose a condition and/or its severity. The list of devices the guidance is applicable to includes electrocardiographs, electronic stethoscopes and pulse oximetry devices.

Under the guidance, the FDA may allow for modifications to the hardware of the specified devices, which will enhance their remote usability. Further, so long as they do not lead to unduly elevated risks, the FDA may allow amendments to approved indications, claims or functionalities of the devices without prior submission of a premarket notification. However, such modifications would be objected if, for example, the device is intended to determine when patients need immediate clinical intervention or is to be primarily relied upon for making clinical diagnoses or treatment decisions concerning COVID-19 or coexisting conditions, as such alterations would create undue risk.

“Increased utilization of non-invasive remote patient monitoring devices may ease burdens on hospitals and other healthcare facilities and reduce the risk of exposure for patients and health care providers to SARS-CoV-2,” commented the FDA in the issued guidance.


Sources:

US FDA. Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19 ) Public Health Emergency.
www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-non-invasive-remote-monitoring-devices-used-support-patient-monitoring-during
[Accessed 03/23/20];
www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-allows-expanded-use-devices-monitor-patients-vital-signs-remotely

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