FDA Updates Guidance on Enforcement for Remote Patient Monitoring Devices

Taking effect immediately is a guidance on non-invasive remote monitoring devices that gather patient physiological data from afar, reducing the need for in-office or in-hospital services.

The guidance, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring,” supersedes the final guidance titled “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”

The 12-page guidance describes the conditions when limited modifications to a device do or do not necessitate prior submission of a 510(k) as well as labeling requirements. The guidance replaces one on the same subject that was issued during COVID and expired with the end of the public health emergency in May, but whose effective date was extended until November.

Read the guidance here.

To read the whole story, click here to subscribe.

Related Topics