Leaders from the U.S. Food and Drug Administration and Centers for Medicare & Medicaid Services (CMS) released a statement on Jan. 18 expressing joint support for increased FDA oversight of laboratory-developed tests (LDTs).
“The FDA and CMS have long stood together in mutual support of FDA oversight of the analytical and clinical validity of LDTs. LDTs play an important role in health care, but when they perform poorly or are not supported by science, they put patients at risk,” write Jeff Shuren, M.D., J.D., director of the FDA Center for Devices and Radiological Health, and Dora Hughes, M.D., M.P.H., acting chief medical officer and acting director of the CMS Center for Clinical Standards and Quality.
According to Shuren and Hughes, expansion of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for the regulation of LDTs would establish “a duplicative system for the oversight of tests … by [creating] more government bureaucracy and inconsistencies.”
The FDA issued a notice of proposed rulemaking regarding LDTs on Oct. 3, 2023, to phase out the current FDA approach to LDTs. The period for public comment ended on Dec. 4. If the proposed rule becomes final, LDTs would fall under the same enforcement approach as other tests. The rule would become effective 60 days after publication in the Federal Register.
“Applying the same oversight approach to laboratories and nonlaboratories that manufacture tests would better assure the safety and effectiveness of LDTs and would remove a disincentive for nonlaboratory manufacturers to develop novel tests that can be available to and used by many laboratories for many patients,” Shuren and Hughes write.