Food and Drug Administration

On May 6, 2024, the Food and Drug Administration (FDA) published the final rule defining how the agency will be changing enforcement discretion on LDTs.

The rule is substantially changed from the preliminary rule published late last year. The changes are directly responsive to many of the concerns raised by ASCLS and other laboratory groups, which universally told FDA the rule, as written, would harm patients.

Unchanged from the preliminary rule is FDA’s decision to not enforce requirements under the FD&C Act and FDA’s regulations for “1976-Type LDTs”; Human Leukocyte Antigen (HLA) tests that are designed, manufactured, and used within a single laboratory certified under CLIA that meets the requirements to perform high-complexity histocompatibility testing when used in connection with organ, stem cell, and tissue transplantation to perform HLA allele typing, for HLA antibody screening and monitoring, or for conducting real and “virtual” HLA crossmatch tests; and tests intended solely for forensic (law enforcement) purposes

The final rule expands the areas where FDA will not be enforcing some or all of the regulations applied to other LDTs. FDA intends to continue enforcement discretion and not enforce most regulations for:

  • LDTs manufactured and performed within the Veterans Health Administration (VHA) or the Department of Defense (DoD);
  • LDTs approved by NYS CLEP15;
  • LDTs manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system
  • Currently marketed IVDs offered as LDTs that were first marketed prior to the date of issuance of this rule and that are not modified, or that are modified in certain limited ways (grandfathering)
  • Non-molecular antisera LDTs for rare red blood cell (RBC) antigens where such tests are manufactured and performed in blood establishments, including transfusion services and immunohematology laboratories and where there is no alternative available to meet the patient’s need for a compatible blood transfusion.

The final rule is voluminous and detailed. Its effects are likely to be felt in most high complexity clinical laboratories.

ASCLS would strongly prefer the focused and risk-based approach to regulating LDTs found in the bipartisan Verifying Accurate Leading-edge IVCT Development Act (VALID), but Congress has failed to move this legislation forward. ASCLS plans to continue the Society’s advocacy for VALID or VALID-like legislative solutions.

As these regulations are now law, ASCLS is preparing educational opportunities for our members on how to implement these new regulations, if they are affected. Time has been reserved at the Joint Annual Meeting in July, and a potential webinar is in the works. It is likely to take some time to know exactly how this new rule will impact clinical laboratories, as experts digest and analyze its details.