COVID-19: FDA Expands List Of Remote Monitoring Devices That Don’t Need Premarket Notification

The US Food and Drug Administration on 28 October updated a guidance document it released earlier this year to allow certain remote monitoring devices on the market without the need for a premarket notification. It includes more standards and devices that the agency says is meant to minimize patient-physician interaction during the coronavirus pandemic.

The FDA in March published the emergency guidance, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The...