FDA Releases Expanded Guidance on Remote Monitoring Devices

On June 8, the Food and Drug Administration (FDA) expanded on guidance it released in March that allows additional medical devices to be utilized for remote monitoring for new indications without specific market clearance. In addition to the originally included electrocardiograph (ECG), cardiac monitor, and ECG software device types, the updated guidance would also include cardiac monitor with cardiotachometer and rate alarm, telephone ECG transmitter and receiver, and several electroencephalograph devices. While the FDA typically allows smaller changes to devices or the expansion of their use to cases that go beyond their claimed indications, also known as “off-label” use, given the need during the COVID pandemic to reduce patient exposure through face-to-face care, the FDA is issuing this expanded guidance to use its discretion to make such expanded uses easier for patients and providers. These expansions will last through the duration of the HHS-declared COVID public health emergency, which began Jan. 27