FDA Imposes New Regulations on Laboratory Developed Tests

07/18/2024

The College of Reproductive Biology (CRB) is a not-for-profit special interest group of the American Association of Bioanalysts (AAB).

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On May 6, 2024, the FDA issued a final rule on laboratory developed tests (LDTs), which has sent shock waves through the field of medical laboratory science. This rule tightens requirements around of the development and use of in-vitro diagnostics devices (IVDs) in laboratories, effectively ending the FDA’s enforcement discretion policy for LDTs. In the world of clinical diagnostics, LDTs are arguably the drivers of innovation. These new regulations placed on the development and use of LDTs in medical laboratories, especially academic and small independent labs, are so overly burdensome and costly that they may prove to limit patient access to care due to laboratory closures.

The FDA insisted that CLIA, and thereby CAP and the Joint Commission as well, lack the expertise to evaluate the clinical necessity and utility of LDTs. All of the aforementioned accrediting bodies, however, require clinical validation of any LDT used in patient care. If the financial burden imposed on laboratories by this final rule wasn’t already detrimental enough, laboratories now must navigate the nuances of dual oversight of LDTs by both FDA and CMS. The implementation of the final rule is broken down into five stages that will be implemented throughout 2025-2028.

So, does this final rule impact ART labs? If so, how? It is hard to say anything definitive at this point in time. Labs performing their own in-house preimplantation genetic testing (PGT) and those performing sperm DNA fragmentation testing may be impacted in some way but, again, it is not presently clear if and how we may be affected as the final rule is implemented. As always, we should keep abreast of current communications/publications and defer to the legal committees and task forces of our professional organizations for guidance. CRB will continue to communicate with our members on this matter as more information becomes available. A timeline of the implementation of the final rule is below:

Stage	Date of Implementation	Policy and Processes Impacted
Stage 1	May 6, 2025	•Compliance with Medical Device Reporting requirements •Correction and removal of tests •Quality system requirements
Stage 2	May 6, 2026	•Implementation of IVD requirements not covered in Stage 3, including: •Registration and listing requirements •Labeling requirements •Investigational use requirements
Stage 3	May 6, 2027	•Compliance with Quality System requirements for IVDs unless excluded by language of the final rule preamble
Stage 4	November 6, 2027	•Premarket review requirements for high-risk LDTs (unless a premarket submission has been received by the FDA).
Stage 5	May 6, 2028	•Expansion of premarket review requirements for low- and moderate-risk LDTs (unless a premarket submission has been received by the FDA).