EUAs and Their Challenges
In response to the COVID-19 pandemic, FDA has granted Emergency Use Authorizations (EUAs) for certain in-demand medical devices. EUA devices are either unapproved medical devices or unapproved applications of approved medical devices that FDA has authorized for temporary use during a health emergency. When all EUAs terminate at the end of the declared health emergency, or if FDA revokes a specific EUA—which can happen at any time—EUA devices revert to their prior status. At that time, the legal protections that support the use of EUA devices on new patients are terminated.
Managing EUA devices is not simple. In fact, the number one topic on ECRI's 2021 Top 10 Health Technology Hazards list is the
Complexity of Managing Medical Devices with COVID-19 Emergency Use Authorization. We encourage you to read that Hazard Report before reviewing the guidance that we present below. The report contains comprehensive information and actionable recommendations to support healthcare facilities in managing EUA devices.
To reduce the risk of using a device on new patients after its EUA has been revoked or terminated, it is important that healthcare facilities monitor specific FDA websites to determine whether EUA devices in inventory still have active EUAs.
Here's a guide to the relevant FDA EUA websites, along with a list of best practices for monitoring those websites to determine EUA device status (i.e., active, revised, revoked, or terminated), and a discussion of how ECRI can help healthcare facilities carry out this work.
FDA EUA Websites
Emergency Use Authorization─This website for general EUA information contains links to FDA's important EUA guidance, COVID-19 Public Readiness and Emergency Preparedness Act (PREP Act) information, and general COVID-19 EUA information for medical devices, drugs, and biological products, as well as specific information for some EUA medical devices.
Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices─This website contains information about, and links to, specific sites for all of the EUA medical devices associated with the COVID-19 public health emergency. Each of those sites provides current information about active EUA device names/models, dates of EUA issue/update, authorized settings (if applicable), and documents such as Healthcare Provider Fact Sheets, Patient Fact Sheets, and device instructions for use (IFU). Following are links to those sites (current as of the publication date of this article):
Blood Purification Devices EUAs
Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs
In Vitro Diagnostics (IVD) EUAs
Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2
Umbrella EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests
Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2
Individual EUAs for Serology Tests for SARS-CoV-2
Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2
Individual EUAs for IVDs for Management of COVID-19 Patients
Decontamination Systems for Personal Protective Equipment EUAs
Infusion Pump EUAs
Personal Protective Equipment EUAs
Umbrella EUA for Surgical Masks
N95 and Other Respirators EUAs
Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China
Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs)
Face Shields and Other Barrier EUAs
Remote or Wearable Patient Monitoring Devices EUAs
Other Medical Device EUAs
Respiratory Assist Devices EUAs
Umbrella EUA for Ventilators and Ventilator Accessories
Authorized Ventilator Tubing Connectors
Authorized Ventilator Accessories
Coronavirus Disease 2019 (COVID-19) EUA—Archived Information—This website is dedicated to revoked or terminated COVID-19 EUA medical devices, drugs, and biological products. It contains product information; dates when product EUAs were issued, revoked, amended, or reissued; links to EUA authorization and revocation letters; and links to documents such as Healthcare Provider Fact Sheets, Patient Fact Sheets, and device IFU.
Best Practices for Monitoring FDA EUA Websites
1. Subscribe to FDA's EUA Email Feed
FDA's Center for Devices and Radiological Health (CDRH) distributes a daily email that summarizes and links to any changes in their authorizations. This daily email contains links to revised, reissued, revoked, and terminated EUAs. Users can subscribe to this email feed at
When you receive a notification that an EUA device in inventory has changed EUA status, proceed to best practice number 2.
2. Confirm the EUA Device Status and Take Appropriate Action
When the status of an EUA model in inventory changes, we recommend checking the relevant EUA device website as soon as possible to confirm the current EUA status. Next, complete the required steps to address the change in EUA status (listed below and illustrated in the decision tree beneath):
1. If the relevant EUA device list has been removed from the website or the specific model has been removed from the EUA device list, the EUA has been revoked or terminated. Follow our recommendations for EUA revocations in
our Top 10 Hazard report.
2. If the EUA has a new date of issue/update, follow our recommendations for EUA revisions in the same report.
How ECRI Can Help Your Facility
To support our members in managing the substantial number of COVID-19 medical device EUAs, ECRI is monitoring the evolving situation and providing EUA device resources such as this article and our
Top 10 Hazards piece. These provide specific recommendations on monitoring FDA's EUA websites and tackling any EUA device changes that are listed there.
ECRI will be posting any substantial changes, such as revoked EUAs or revisions to umbrella EUAs, as reports in
Health Devices Alerts database. That database also includes already-published alerts such as the following:
In addition, ECRI analysts are available if you have questions regarding the EUA status of specific devices, including those currently being used at your facility. Please contact HealthDevices@ecri.org with any concerns or questions.
Finally, if you have experienced difficulty in managing the COVID-19 EUA process, or have specific processes that have worked well for your facility, we ask that you please share your experience with us at HealthDevices@ecri.org. If appropriate, we will share these experiences and best practices with the rest of our membership.