FDA guidance encourages remote patient monitoring during pandemic

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In response to the COVID-19 outbreak, FDA released guidance Friday encouraging companies and healthcare professionals to expand the use of remote monitoring technology to "help eliminate unnecessary patient contact and ease the burden on hospitals, other health care facilities, and health care professionals."

The agency's recommendations apply to non-invasive monitoring devices, such as thermometers, electrocardiographs, stethoscopes, pulse oximeters and cardiac monitors, and those that measure blood pressure and respiratory rate.

FDA said in its guidance it will not object to certain "modifications to the indications, claims or functionality" of monitoring devices if they do not create undue risk and if the device is intended to support or provide adjunctive recommendations to a healthcare professional or patient about prevention, diagnosis, or treatment of COVID-19 or co-existing conditions.

FDA said it will also allow for hardware or software modifications that increase remote monitoring capabilities of devices.

Finally, the agency recommended that software such as mobile apps may be useful to monitor patients with COVID-19 or co-existing conditions and to provide clinical decision support.

Friday's guidance follows recommendations from FDA Wednesday on how drug developers can adapt clinical trials to the pandemic by altering patient monitoring strategies, endpoints and other aspects of their protocols (see "FDA Stresses Patient Safety, Studies' Integrity Amid Outbreak").

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.

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