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HHS Determines FDA Can’t Regulate Lab-Developed Tests Without Formal Rulemaking

August 21, 2020

HHS said yesterday that it has determined that the FDA will not require premarket review of laboratory-developed tests (LDTs) without notice-and-comment rulemaking. This means that the FDA cannot expand its authority over LDTs through guidance and other informal issuances. As reported by Genome Web, it also means that laboratories will be able to “offer LDTs for SARS-CoV-2 without first taking them through FDA’s Emergency Use Authorization process”. 

Whether and to what extent the FDA has authority over LDTs has been a controversial issue for years, with some laboratory stakeholders favoring FDA regulation and others strongly opposed. 

Legislation reflecting these two camps has been introduced in Congress. The Verifying Accurate, Leading-edge IVCT Development Act (VALID), introduced by Senators Richard Burr (R-NC) and Michael Bennet (D-CO) and Representatives Larry Buchson (R-IN) and Diana DeGette (D-CO), would grant the FDA authority to regulate LDTs through a new risk-based framework, while the Verified Innovative Testing in American Laboratories Act (VITAL), introduced by Senator Rand Paul (R-KY), would place LDTs under the oversight of CLIA regulations.