FDA updates EUA acceptance criteria for laboratory developed tests (LDTs)

The US Food and Drug Administration (FDA) has updated its Frequently Asked Questions on the development and performance of diagnostics for SARS-CoV-2, which includes the agency’s plan to decline to review emergency use authorisation (EUA) requests for laboratory developed tests (LDTs).

What does this decision mean? Laboratories developing tests solely to be used within the lab (laboratory developed tests, or LDTs) do not need to undergo pre-market review by the FDA. It is important to note, this pre-market review requirement has almost never been enforced. In the case of future pandemics, this decision will allow labs to quickly develop and utilise tests. The decision is applicable to all LDTs, regardless of what they are testing for.

This decision was made by the Department of Health & Human Services, as part of an on-going departmental review of the response to COVID-19. The FDA said “we are currently in a different phase of the pandemic with respect to tests than we were previously, where many COVID-19 tests are now authorised to be run in labs. We prioritise review of EUA requests for tests taking into account a variety of factors, including those discussed in the Emergency Use Authorisation of Medical Products and Related Authorities Guidance, such as the public health need for the product and the availability of the product.”

Will this lead to low quality COVID-19 tests flooding the market?

LDTs,by definition, cannot be sold outside of the laboratory in which they were developed. There is no reason to believe that complying with law will have any effect on the quality of LDTs. Every COVID-19 test, including LDTs, are still regulated by the US federal government.

However, any direct-to-consumer test, including tests shipped by commercial labs, are still required to go through premarket review at FDA, as they are medical devices under applicable statutes. The same would apply to the registration of these diagnostics and medical devices in markets outside of the US with the relevant regulatory requirements for each market.