FDA Issues Temporary Guidance Regarding Non-Invasive Remote Monitoring Devices

Guidance for industry plus Food & Drug Administration Staff to support patient monitoring during the COVID-19 public health emergency

The Food and Drug Administration (FDA) has issued temporary guidance regarding device or software changes that could support remote patient monitoring during the COVID-19 public health emergency.  The three major takeaways include:

• The desired outcome is to increase access to important physiological data without the need for in-clinic visits.
• The devices covered by the guidance include thermometers, ECGs and ECG software, cardiac monitors, pulse oximeters, non-invasive blood pressure measurement devices, electronic stethoscopes, and devices that can monitor respiratory rate or breathing frequency.
• FDA does not intend to object to limited modifications to the following areas without resubmission for clearance as long as those changes do not create undue risk: indications, claims, functionality, hardware/software changes.

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