Remote Monitoring Guidance
Navigating the Regulatory Pathway during a Global Pandemic
What are the motivations for the COVID-19 Remote Monitoring guidance?
- Leverage patient monitoring technology to help eliminate unnecessary patient contact;
- Ease the increased healthcare burden of diagnosis and treatment of patients with COVID-19;
- Provide patient monitoring for conditions unrelated to COVID-19 remote from healthcare facilities.
What eight medical device types are covered by the guidance? View All Devices.
- Clinical electronic thermometer or Pulse Oximetry (SpO2);
- Cardiac monitor, Electrocardiograph (ECG) or software;
- Non-invasive Blood Pressure or Electronic Stethoscope;
- Respiratory Rate/Breathing Frequency.
What are acceptable modifications to indications, claims or functionality?
- The device is intended to capture and display physiological measurements; and
- The device recommends prevention, diagnosis or treatment of COVID-19; and
- The basis for any diagnostic/treatment recommendations can be reviewed independently.
What kind of modifications are not envisioned by this guidance?
- Adding functionality to acquire or analyze signals not present in the FDA-cleared device.
- The device is intended to be solely or primarily relied upon for diagnosis or treatment decisions.
- The device determines when patients need immediate clinical intervention to assure patient safety.
What are expected label updates?
- Describe data on device performance, and potential risks for COVID-19 or co-existing conditions.
- Include disclaimer that device recommendations should not be solely or primarily relied upon.
- Define use conditions (spot-checking, trend monitoring, or continuous monitoring).
- Delineate FDA-cleared indications and claims from those that are not FDA-cleared.
- Provide adequate lay instructions if device usage is expanding to include home settings.
What are envisioned COVID-19 remote monitoring changes?
- Hardware or software modifications that enable wireless connection (Bluetooth, Wi-Fi, or Cellular) and transmission of patient’s measurements to healthcare providers. Changes cannot impact physiological measurement algorithms and should be implemented in accordance with FDA recognized standards (electrical, wireless medical devices, Medical Device Software, cybersecurity).
What are examples of COVID-19 Clinical Support Software?
- Software that analyzes medical information about a patient diagnosed with COVID-19 and recommends follow up care while citing for the recommendation basis.
- Software that recommends medical device treatment for a patient with confirmed or suspected COVID-19 and cites the FDA labeling basis of other sources.
- Software that provides current practice treatment guidelines for COVID-19 or co-existing conditions based on patient diagnosis and cites the guideline source.
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