HHS Reverses Course on LDTs, Bars FDA from Requiring Premarket Review

In a surprising reversal, the U.S. Department of Health and Human Services (HHS) has declared that the Food and Drug Administration (FDA) does not have the authority to require clinical laboratories to seek pre-market approval of laboratory tests they have created. In a statement, HHS said, “[It] has determined that the FDA will not require premarket review of laboratory developed tests (LDT).” The new policy breaks with what former FDA Administrator Scott Gottlieb said in a series of tweets was “long settled [policy] that LDTs were medical devices, subject to FDA oversight.”

The new policy is not absolute. The FDA can still regulate these devices; however, it has to use the formal notice-and-comment rulemaking process, which is far more cumbersome and time consuming than the use of the “guidance documents, compliance manuals, website statements, or other informal issuance[s]” the Agency has used in the past. In the absence of FDA approval, clinical laboratories using LDTs remain under the oversight of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

Though not required, clinical laboratories may voluntarily seek FDA approval. For those laboratories with unapproved COVID-19-related LDTs, one advantage of obtaining FDA premarket review or authorization is PREP Act eligibility. The PREP Act (Public Readiness and Emergency Preparedness Act) provides immunity from liability for claims against “countermeasures” to diseases that constitute a public health emergency. Countermeasures include laboratory tests. For more on the PREP Act, click here.

HHS’s reversal of policy has not gone unnoticed by Congress. Frank Pallone, Chair of the powerful House Energy and Commerce Committee, recently criticized the move in a statement seeking an explanation from HHS Secretary Alex Azar.

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