Skip to content

FDA scales back C-19 EUAs

Published by Isabella Greenock, Medical Device Paralegal on

The FDA has recently announced a scaling back of Emergency Use Authorisations (EUAs) for Covid-19 tests, with the majority of manufacturers now being asked to pursue traditional approval pathways in order to bring new products to market.[1]

EUAs were initially introduced for in vitro diagnostic Covid-19 tests (whether detecting past or current infection) in February 2020. They allowed products to be marketed in the US based on best available evidence, without other evidence that would typically be required for device approval/clearance.[2] The aim of these EUAs was to expedite the regulatory approval process in line with the broader policy goal of increasing the testing capacity (similar reasoning has also recently been used to justify EUAs for monkeypox test devices).[3] However, as the pandemic has progressed and the US’s capacity has increased, the FDA no longer considers it suitable for EUA requests to be made for most Covid-19 testing devices. 

While the FDA has not completely ruled out the possibility of reviewing EUA requests for future Covid-19 tests, their comments on current testing capacity indicate that the Agency does not consider it likely that such devices will meet the requirements for these authorisations going forward. Instead, manufacturers of new Covid-19 tests (that is, tests not already subject to an EUA or those for which EUA requests are pending) are now encouraged to submit their applications under one of the following traditional premarket review pathways: 

  • De novo classification - for products with no legally marketed predicate device
  • 510(k) clearance - for products which are substantially equivalent to another legally marketed device.

Manufacturers must now establish which pathway is most suitable for their product before submitting the relevant application in full. Unlike with EUA applications, it will no longer be possible to waive requirements relating to general controls, device listing and quality systems, among other things. 

It is therefore important that manufacturers understand the full extent of the legal rules now applicable to Covid-19 tests in the US. Our Health Care Regulatory Explorer can help you navigate this regulatory maze - providing an explanation of which laws apply to your product, as well as tailored resources on the requirements you will need to meet to bring it to market. Please sign up using the form below to register your interest. 

More generally, the FDA’s approach towards Covid-19 tests raises questions of whether similar announcements should be expected for other devices subject to EUAs as a result of the pandemic (such as respiratory protective equipment and certain ventilators/ventilator accessories), as well as what will happen if other countries follow suit in scaling back their Covid-19 regulatory flexibilities. We are keeping a close eye on these developments so subscribe to our newsletter to stay up to date!

 

[1] FDA News Release, Coronavirus (COVID-19) Update: FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test (27 September 2022)

[2] FDA, Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19

[3] FDA, Monkeypox Emergency Use Authorizations for Medical Devices