On Dec. 4, the American Clinical Laboratory Association (ACLA) submitted comments on the U.S. Food and Drug Administration proposed rule regarding laboratory-developed tests (LDTs).
The ACLA expressed “grave concerns” with the proposed rule, advocating for a withdrawal of the proposal. According to the ACLA, the proposed rule would hinder the ability of laboratories to innovate and would limit patient access to LDTs. Additionally, the ACLA explains that the Clinical Laboratory Improvement Amendments and state laws already offer sufficient oversight of LDTs, with public and private payers scrutinizing the clinical validity of the tests before making coverage decisions. Finally, the ACLA called the proposal “a regulatory overreach,” as “LDTs are not devices, and FDA lacks authority to regulate them as such.”
The rule would designate LDTs as medical devices, subject to the same enforcement approach as in vitro diagnostic products. The FDA maintained that all public comments must be submitted by Dec. 4, despite requests from the ACLA, the College of American Pathologists, and other trade organizations to extend the commenting period to 120 days due to the complexity of the proposed rule.