Remote or Wearable Patient Monitoring Devices EUAs
March 24, 2023 - The FDA has finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for:
- Developing a transition implementation plan,
- Submitting a marketing submission, and
- Taking other actions with respect to these devices.
The FDA encourages stakeholders to review the two final guidances, attend the webinar, and reach out to the FDA if they have questions or concerns. In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
- Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023
Remote or wearable patient monitoring devices include (1) non-invasive remote monitoring devices that measure or detect common physiological parameters and, (2) non-invasive monitoring devices that wirelessly transmit patient information to their health care provider or other monitoring entity. The FDA has issued EUAs for certain remote or wearable patient monitoring devices to help increase the availability of monitoring and treatment of patients and to help address reduction of healthcare provider exposure to SARS-CoV-2 during the COVID-19 pandemic.
The table below lists the remote or wearable patient monitoring devices authorized for use during the COVID-19 public health emergency.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.
|Date EUA Issued||Device Type||Letter of Authorization||Fact Sheets||Other Documents||Assigned Product Code|
|04/21/2020||Remote Patient Monitor||IntelliVue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH||QLJ|
|04/26/2020||Remote Patient Monitor||VitalConnect, Inc., VitalPatch||QNY|
|05/05/2020||Remote Patient QT Interval Monitor||PhysiolGuard, ECG-QT Analysis System||QNY|
|05/08/2020||Patient Isolation Transport Unit (PITU)||Patient Isolation Transport Unit (PITU) Device||QLE|
|05/11/2020||Nurse Call System||Ascom(US), Inc., teleCARE||QNZ|
|05/14/2020||Remote Patient QT Interval Monitor||G Medical Innovations, Ltd., VSMS Patch||QNY|