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- FDA Plans to Finalize LDT Rule by April 2024
The Food and Drug Administration (FDA) plans to finalize the proposed rulemaking on laboratory-developed tests (LDTs) by April 2024, according to a work plan published by the Office of Management and Budget (OMB). So far, the FDA has received over 6,700 comments on the rule. Citing substantial undue regulatory burdens and costs on laboratories, the CAP called on the FDA to make significant changes to its proposed regulation of LDTs in a letter to the FDA on December 4.
The proposed regulation would phase out the current enforcement discretion approach by the FDA for LDT oversight. The FDA would classify over the course of five years in vitro diagnostics (IVDs) offered as LDTs as Class I, II, or III medical devices depending on risk to patients.
In its comments to the FDA, the CAP recommended that the following categories of the proposed rulemaking should continue under the FDA’s enforcement discretion policies:
- Exempting tests offered prior to the rule’s enactment
- Forensic, Human Leukocyte Antigen (HLA), and manual tests
- LDTs developed and offered locally by a clinical laboratory
- Adverse events reporting
- Quality systems
- Corrective action and removal
- Labeling