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- LDT Court Decision: Answers to 5 Questions
Here are answers to five top questions you might have after a US District Court judge nullified the Food and Drug Administration (FDA) regulation on the oversight of laboratory-developed tests (LDT) on March 31.
What effect did the judge’s decision have on the LDT rulemaking?
The judge's decision canceled the FDA LDT rulemaking and all the rulemaking’s associated requirements and guidance documents.
Do we need to still comply with any of the FDA's new LDT oversight requirements on May 6?
No. Laboratories no longer need to comply with Stage 1 FDA regulatory changes that were set to take effect on May 6, 2025. Laboratories do not need to comply with the latter stages of the rulemaking, either.
Will the Department of Health and Human Services (HHS) or FDA appeal the ruling?
We have seen no indication that the government will appeal the court ruling.
How does the court decision affect CLIA?
The judge’s decision does not impact CLIA laboratory regulations. CLIA requirements for laboratories remain in effect as they did prior to the FDA LDT rulemaking.
What effect does the court decision have on CAP accreditation checklists?
CAP laboratory accreditation checklists, including our most recent edition, have no changes related to the FDA LDT final rule. CAP accreditation checklists do include requirements for LDT method validation, adverse event reporting, and quality management to ensure CLIA compliance. Visit our Accreditation Resources within e-LAB Solutions Suite for an array of educational resources to help you and your laboratory maintain compliance.