On August 19, 2020, the US Department of Health and Human Services (HHS) announced that the Food and Drug Administration (FDA) no longer requires the premarket review of laboratory developed tests (LDTs), including certain tests used to detect COVID-19. A type of in vitro diagnostic test, an LDT is designed, manufactured, and used within a single lab. Although LDTs are typically not used during a pandemic, the FDA loosened restrictions in February to increase the widespread availability of COVID-19 testing. With this new update, certain individual laboratories will be allowed to distribute the COVID-19 tests that they develop without first submitting documentation to the FDA and undergoing a premarket review.
The HHS stated that the move is a part of their “ongoing department-wide review of regulatory flexibilities enacted since the start of COVID-19.” However, some experts are concerned about how the change will impact the accuracy of the affected COVID-19 tests.
Although most coronavirus tests currently used in the United States are made by device manufacturers and still subject to FDA review, the LDTs addressed in this new policy are used widely as well. The decision will impact numerous laboratories, including some owned by Quest Diagnostics and LabCorp as well as labs at academic medical centers. The announcement does not affect labs that already have an EUA for an LDT designed to detect SARS-CoV-2 (the virus that causes COVID-19) or its antibodies.
Previously, private and commercial laboratories would submit clearance, approval, or emergency use authorization (EUA) applications to the FDA to develop and use their own COVID-19 tests. Although labs are still allowed to voluntarily submit these applications, they aren’t required to do so. However, if they do not receive approval, clearance, or authorization from the FDA, they will not be eligible for coverage under the Public Readiness and Emergency Preparedness (PREP) Act. They will also remain subject to regulation by the Centers for Medicare & Medicaid Services.
Background of FDA Oversight of LDTs
LDTs are designed for rapidly changing conditions or quickly advancing scientific research, and for many years they didn’t require FDA premarket review due to their simplicity and limited availability. However, over time LDTs were increasingly developed to diagnose acute diseases and conditions with the potential to impact public health, like COVID-19, so the FDA began to necessitate stronger regulation. The FDA actively regulated LDTs as medical devices. They were not to be used for clinical diagnosis without the FDA’s approval, clearance, or authorization.
In the first several weeks of the COVID-19 pandemic, after the CDC delayed its launch of widespread testing, many labs turned to LDTs. By late February, the FDA loosened LDT oversight to increase the availability of testing.
By eliminating FDA premarket review altogether, this recent announcement is expected to have a profound impact on the FDA’s regulation of LDTs in the context of COVID-19 and more generally.
A Mixed Response
Some health experts are applauding the move, stating that it will remove the “regulatory hurdle” that arose when COVID-19 was declared a public health emergency. Some approve of the decision because they believe LDTs should not fall under the jurisdiction of LDTs, arguing that the tests are better described as medical procedures than medical devices.
Other health experts find the change concerning and evidence of a bureaucratic quarrel between the HHS and FDA, in which the HHS is threatening the FDA’s authority. Critics are concerned that this could negatively impact the accuracy of individual labs’ tests, allowing unreliable tests (that likely wouldn’t have received FDA approval) to come to market. In addition, some are questioning the decision to make this change during a pandemic, as it could lead to the widespread use of inaccurate and unreliable tests.
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