New Rule to Regulate Laboratory Developed Tests Proposed by FDA
By Christopher Hanson
The U.S. Food and Drug Administration (FDA or the Agency) recently proposed a new rule that has sparked controversy among clinical laboratories and medical device manufacturers. The current regulatory landscape for laboratory developed tests (LDTs) will completely shift under the proposed rule. FDA has long considered LDTs to be medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). But, for nearly 50 years, the Agency has exercised “enforcement discretion” and not actively regulated most LDTs under FDA’s pre- and post-market medical device regulatory authorities. Instead, developers of LDTs have largely been subject to clinical laboratory regulatory requirements administered by the Centers for Medicare & Medicaid Services (CMS). Citing public health concerns and Congressional inaction in implementing diagnostics regulatory reform, FDA announced in its proposed rule that it intends to phaseout the historical enforcement discretion policy for LDTs.
FDA defines an LDT as an in vitro diagnostic (IVD) that is intended for clinical use and that is designed, manufactured, and used within a single certified laboratory that meets the regulatory requirements under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity testing. The proposed rule adds a single sentence to the IVD product regulations at 21 CFR Part 809 clarifying that IVDs are considered medical devices even when the manufacturer of the product is a laboratory. If finalized, the rule would implement a four-year plan to subject LDTs to FDA’s pre- and post-market medical device regulatory requirements. In the preamble to the proposed rule, FDA estimates that approximately 50% of LDTs would require Agency premarket review under the new policy.
