FDA may re-regulate lab-developed tests. The U.S. Department of Health and Human Services has revoked a policy enacted by the Trump administration in August 2020 that limited the FDA’s ability to address certain problematic COVID-19 testing.
The policy, enacted in August, instructed the FDA not to require a premarket assessment for LDTs, including premarket approval (PMA) or approval (510(k)), and emergency use authorization (EUA), even in situations where they perform poorly.
By withdrawing the policy, HHS said it will help ensure the COVID-19 tests are working as intended. As of today, HHS no longer has a policy on LDTs that is separate from the FDA’s long-standing approach to this matter.
Today, the FDA said it is also updating its policy for COVID-19 testing, including COVID-19 LDTs. This policy considers the importance of test availability, reliability and accuracy.
“In addition to vaccination efforts, testing remains a cornerstone of the national response to the pandemic and plays a pivotal role in helping Americans return to work, school and other important activities, especially as the holiday season approaches. The FDA remains committed to helping increase the availability of tests that will have the greatest impact on the nation’s ongoing COVID-19 testing needs, such as home and point-of-care diagnostic tests that can be produced in high volumes. ” said Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health. “By focusing our assessment on these types of tests and ensuring that available tests monitor appropriately, we can better respond to the pandemic as the country’s testing needs continue to evolve.”
According to a report by The Washington Post, the original policy change sparked intense disagreement between Stephen Hahn, then FDA commissioner, and then HHS secretary Alex Azar. The Post’s report also said the policy came as a shock to many at the FDA.