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Today, the U.S. Food and Drug Administration (FDA) issued a guidance, which takes effect immediately, titled: Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring. This guidance 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Disease 2019 (COVID-19) Public Health Emergency,” which was intended to remain in effect until November 7, 2023, unless superseded by a revised final guidance.
Non-invasive remote monitoring devices are used to obtain patient physiological data while reducing the need for in-office or in-hospital services.
This guidance:
- Fosters the continued availability of safe and effective medical devices while being flexible about certain modifications made to non-invasive monitoring devices.
- Builds upon guidance for non-invasive remote monitoring devices specific to the COVID-19 public health emergency (PHE).
- Provides recommendations regarding modifications to indications, functionality, and hardware or software intended to increase remote monitoring availability or capability.
- Provides recommendations about the labeling and/or validation appropriate to support such modifications relevant to the enforcement policy.
Questions?
If you have questions about this guidance, contact the Division of Industry and Consumer Education.
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