Last year, the Trump administration determined that the FDA would no longer require premarket review of laboratory-developed tests, known as LDTs. Prior to that determination, laboratories were required to submit applications to develop and use their own Covid-19 tests. But the move to limit that process meant that makers of Covid-19 tests developed by certain labs — such as Quest Diagnostics, LabCorp or those at academic medical centers — could distribute their tests without the need to first submit documentation for review by the FDA before they were marketed.
“The policy directed FDA not to require premarket review for LDTs, including premarket approval (PMA) or clearance (510(k)), and emergency use authorization (EUA), even in situations where they have poor performance. By withdrawing the policy, HHS is helping to ensure that COVID-19 tests work as intended. Effective today, HHS no longer has a policy on LDTs that is separate from FDA’s longstanding approach in this area,” HHS Secretary Xavier Becerra said in a statement Monday.
Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a separate statement on Monday that Covid-19 testing remains a “cornerstone” of the nation’s response to the ongoing pandemic.
The agency said its actions were aimed and increasing access to “accurate and reliable” Covid-19 tests.
“The FDA remains committed to helping to increase the availability of tests that will have the biggest impact on the nation’s ongoing COVID-19 testing needs, such as at-home and point-of-care diagnostic tests that can be produced in high volumes,” Shuren said in part. “By focusing our review on these types of tests, and helping to ensure that available tests have appropriate oversight, we can better respond to the pandemic as the nation’s testing needs continue to evolve.”
When the previous policy was announced last year directing the FDA not to enforce premarket review requirements for lab-developed tests, some health experts applauded the move while others expressed worry about what it could mean for Covid-19 testing accuracy.