FDA Issues Temporary Guidance Regarding Non-Invasive Remote Monitoring Devices

March 31, 2020

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.

Exponent's team of qualified experts can provide additional guidance if you believe this FDA announcement may apply to your business. Please see the list of contact details below to connect directly with one of our experts.