Health Law Blog

FDA Enforcement – Serology Testing for COVID-19

As laboratories across the country work to adapt to the new environment that COVID-19 has presented, they are navigating a new regulatory field to get their COVID-19 tests up and running. The FDA has provided several sources of guidance with regard to COVID-19 diagnostic testing, including serology testing.

Serology tests are meant to measure the level of anti-bodies in blood when an individual is fighting an infection. Serology tests are important during the current public health crisis as they can help us determine who has already had COVID-19 and therefore may now be immune to the virus.

While diagnostic testing generally requires FDA authorization prior to its use, the FDA has made some exceptions during the public health emergency. Specifically, in March, the FDA issued a policy providing that serology tests can be used and marketed without FDA authorization so long as they appropriately evaluate their tests for accuracy, have the appropriate labeling (this includes making the consumer aware that such test has not yet been authorized by the FDA) and follow the appropriate FDA guidance that has been provided for serology testing. While this has helped to more efficiently develop and implement serology tests, it has also caused some difficulties.

Many developers have been claiming to have authorization from the FDA for their serology tests. The FDA has currently only authorized one company’s serology test through the FDA’s emergency use authorization process to date. While many of these developers may currently be using serology testing with the appropriate labeling and in accordance with all other FDA appropriate guidelines, that does not mean that their product has been authorized. Making an assertion that a product is FDA authorized can give a consumer the wrong idea as to its accuracy. The FDA has suggested that serology tests that may be being used without authorization, should not be the only source of testing for positive results, as they have not yet been authorized and are also meant to test antibodies, and not to diagnose COVID-19.

The FDA has recently been made aware that developers are falsely claiming that their serology tests have been authorized and have warned that these developers may face enforcement in the near future including possible product seizures. It is important for those testing to follow all FDA requirements.

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