FDA Regains Authority over Laboratory Developed Tests

The U.S. Department of Health and Human Services Secretary Xavier Becerra, on November 15, withdrew a Trump Administration-era policy that stripped the U.S. Food and Drug Administration (FDA) of authority over laboratory-developed tests (LDTs). Becerra’s statement restores FDA authority over LDTs.

That policy, first announced on August 19, 2020, related specifically to laboratory-developed tests. An LDT is a type of test that is generally designed, manufactured, and used in a single laboratory. The 2020 policy directed FDA not to require premarket review for LDTs, including premarket approval or clearance (510(k)), and emergency use authorization, even in situations where they have poor performance. Instead, CMS was tasked with oversight under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

In conjunction with Secretary Becerra’s announcement, the FDA published a news release quoting the director of the FDA’s Center for Devices and Radiological Health, Jeff Shuren, MD, JD. “In addition to vaccination efforts, testing remains a cornerstone of the national response to the pandemic and plays a central role in helping Americans get back to work, school and other important activities, particularly as the holiday season approaches,” Dr. Shuren said. “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.” 

The switch in agency oversight is likely to shape congressional debate over which agency should oversee LDTs and what that oversight should look like. Currently, two bills have been introduced in Congress to address the regulation of LDTs and in vitro diagnostics. The Verifying Accurate Leading-edge IVCT Development Act of 2021” (the “VALID Act”)(S.2209/H.R.4128) would provide an FDA-centric, risk tiered oversight system, whereas the Verified Innovative Testing in American Laboratories Act of 2021 (the “VITAL Act”)(S.1666) would provide a CLIA oversight scheme that put in place at the end of 2020 by the Trump Administration.
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