Emergency Use Authorization and Enforcement
FDA Response to COVID-19 – Remote Monitoring Devices
Remote Patient Monitor EUAs
Since 21 April 2020, two (2) EUAs have been released for patient monitoring. IntelliVue Patient Monitors (Philips Medizin Systeme Boeblingen GmhB) has been issued emergency authorization for use for remote patient monitoring by healthcare professionals to reduce exposure to COVID-19. VitalPatch (VitalConnect, Inc.) is a device currently on the US market given authorization to expand indications. VitalPatch is cleared for wireless remote monitoring for continuous collection of data including heart rate, ECG, heart rate variability, R-R interval, respiratory rate, body temperature, skin temperature, activity, and posture. Authorization has been granted for automated arrhythmia detection of the QT interval of the ECG for patients undergoing treatment for COVID-19 with drugs that can prolong QT intervals and may cause life-threatening arrhythmias (hydroxychloroquine, especially in combination with azithromycin).
FDA is not requiring premarket notifications for changes to indications, claims, functionality, hardware or software to FDA-cleared non-invasive remote monitoring devices that detect common physiological parameters to support patient monitoring. Cardiographs, thermometers, pulse oximetry, and respiratory rate devices are some products that may utilize remote monitoring. Changes to support expanded remote capabilities to avoid COVID-19 infection during this time will not require a 510(k) if changes to not increase undue risk. Increasing or implementing wireless or Bluetooth systems, changes to use environment indications, and including COVID-19 in indications, are considered to be changes that do not add undue risk to the devices.
Changes or modifications to the device should be accompanied by changes to labeling to indicate differences to FDA-cleared or approved monitoring device. Prominent notice to both patients and HCPs that recommendations provided by device are adjunctive and should not be solely or primarily relied upon to prevent, diagnose, or treat COVID-19. Information on device’s new claims and indications and use conditions are to be included, particularly whether device is intended for spot-checking, trend monitoring, or continuous monitoring. All changes to hardware and software are recommended to be designed, evaluated, and validated in accordance with FDA recognized standards and include developed cybersecurity controls to ensure security and maintain functionality and safety.