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# Non-Invasive Monitoring Enforcement Guide
- URL: https://www.fdaweb.com/non-invasive-monitoring-enforcement-guide/
- Published: 2023-10-18T12:00:00.000Z
- Updated: 2026-09-14T14:13:39.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155592

FDA has published a guidance, *Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring*, to extend the enforcement policies for the devices beyond the 5/11 expiration of the Covid-19 public health emergency and a 180-day period announced in a 3/13 *Federal Register* notice. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-non-invasive-remote-monitoring-devices-used-support-patient-monitoring?ref=fdaweb.com) says the agency has evaluated the benefits and risks to patients and healthcare providers of exercising certain enforcement policies, including identifying certain device types for which enforcement policies might be appropriate, and assessing other lessons learned from the implementation of Covid-19-related enforcement policies for certain device types.

“Although this guidance has been revised to remove any expiration date, among other things, for certain device types,” the agency says, “FDA intends to continue to monitor the situation and may make further revisions to the guidance, withdraw the guidance, or pursue other regulatory actions, as appropriate.”

The guidance is being implemented without prior public comment because, FDA says, it has determined that prior public participation for this guidance is not feasible or appropriate.