TNHLLDTS2024 - CME/CMLE - Virtual Town Hall: An Overview of the FDA’s Final Rule on Laboratory Tests-ASCP Fact Sheet on FDA LDT Final Rule

ASCP Fact Sheet on FDA LDT Final Rule

Pdf Summary

The FDA’s Final Rule on Laboratory Developed Tests (LDTs) clarifies that in vitro diagnostic products (IVDs), including LDTs, are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). An LDT is generally defined as an IVD intended for clinical use, designed, manufactured, and utilized within a single CLIA-certified laboratory. The FDA will expect all IVDs, including LDTs, to comply with its regulatory requirements once the rule is fully implemented.<br /><br />The FDA will phase out its broad "enforcement discretion" policy, which previously allowed some LDTs to bypass certain regulatory requirements. High-risk LDTs will be subject to stringent premarket application and submission requirements, while low and moderate risk LDTs will undergo premarket review. Some LDTs, such as "1976-type" tests, Human Leukocyte Antigen (HLA) tests, forensic tests, and those used in Veterans Health Administration and Department of Defense laboratories, will still benefit from full enforcement discretion and will not be subject to FDA's other regulatory controls.<br /><br />Partial enforcement discretion applies to specific LDTs, including those marketed before May 6, 2024, certain healthcare system LDTs, non-molecular antisera LDTs for rare RBC antigens, and NYS CLEP-approved tests. Although exempt from premarket review and most Quality System (QS) requirements, these LDTs must comply with other regulations, such as medical device reporting.<br /><br />Modifications to FDA-approved tests and LDTs introduced before the implementation date but significantly altered will need to go through premarket review and meet QS requirements. The implementation schedule spans five stages over four years, gradually ending enforcement discretion for facets like MDR, registration, labeling, QS, and premarket review requirements for both high and low-risk LDTs.<br /><br />Overall, the rule aims to standardize regulatory oversight for LDTs, ensuring higher safety and efficacy standards.

Keywords

FDA

Final Rule

Laboratory Developed Tests

LDTs

in vitro diagnostic products

IVDs

regulatory requirements

enforcement discretion

premarket review

Quality System