Remote or Wearable Patient Monitoring Devices EUAs
August 11, 2026 - The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023. The COVID-19 enforcement policy guidances within scope of the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.
The end of the COVID-19 PHE and certain COVID-19 enforcement policy guidances no longer being in effect do not impact the FDA's ability to authorize devices, including tests, for emergency use. Existing emergency use authorizations (EUAs) for devices relating to COVID-19 remain in effect under section 564 of the Federal Food, Drug, and Cosmetic Act.
On June 29, 2026, the HHS Secretary determined that circumstances no longer exist justifying the authorization of emergency use of (1) in vitro diagnostics for detection and/or diagnosis of the SARS-CoV-2 virus; (2) personal respiratory protective devices; and (3) medical devices, including alternative products used as medical devices. On the basis of this determination, the HHS declarations authorizing emergency use of these medical devices for COVID-19 will be terminated, effective December 26, 2026. On the effective date of this termination, the COVID-19 emergency use authorizations (EUA) for devices currently listed on this website will no longer be in effect.
The FDA encourages manufacturers of devices issued EUAs related to COVID-19 to review the guidance: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19), which outlines the FDA's recommendations and expectations to such manufacturers to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end. Additional information is provided on the page FAQs: What happens to EUAs when a public health emergency ends?
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 |