When COVID-19 first emerged in the United States, the pandemic sparked a rush to provide protective gear, develop tests to detect the disease, and implement effective containment strategies to stop the spread. The Food and Drug Administration (FDA) used its Emergency Use Authorization (EUA) process to facilitate the rapid market introduction of medical devices (authorized but unapproved) to combat the emergent public health threat. Unfortunately, performance problems with some medical devices stymied initial containment efforts, arguably resulting in greater spread and suggesting a need for improvement in the EUA process.
By reviewing the statutory requirements of the EUA process, this Note examines how the process is intended to function and where it came up short during the COVID-19 pandemic. The Note then identifies the medical devices (diagnostic tests and personal protective equipment) that are most likely to require EUAs during a potential future pandemic and reveals a regulatory gap in quality control procedures that enabled nonperforming devices to reach the market during the current pandemic. Finally, the Note proposes a solution that would likely fill this regulatory gap and help the FDA achieve its goals in the event of another infectious disease emergency. The solution is to require an independent test of the manufactured product to ensure it meets its performance specifications before releasing the medical device to the market.
Laura Kent-Jensen, Emergency Use Authorizations in the Time of Coronavirus, 2022 ULR 413 (2022). doi: 10.26054/0d-5nj3-gp2r.