FDA Revises Enforcement Policy for Non-Invasive Remote Monitoring Devices

November 1, 2023 – The Food and Drug Administration (FDA) recently issued a final guidance document to provide clarification on its enforcement policies and premarket review expectations for certain non-invasive remote monitoring used for patient monitoring at the conclusion of the COVID-19 public health emergency titled “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring.”

The enforcement policy described in the guidance document applies to modified devices where the original device was a legally marketed, non-invasive remote monitoring device listed in the guidance that measures or detects common physiological parameters and that is used to support patient monitoring.

The guidance is intended to describe the enforcement policy for limited modifications to the indications, functionality, or hardware or software of device types in the scope of the guidance without prior submission of a 510(k) where such submission would be required.