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Why is this topic important?

A recent FDA rule revision has eliminated the FDA approval exemption for new lab developed tests (LDTs). Existing LDTs are grandfathered in but will also be subject to FDA regulation under some circumstances. This may have an effect on the development of new diagnostic assays, particularly affecting molecular diagnostics and esoteric and routine testing in transplantation and other fields of medicine.

Additional Q&A:

The panel has also included answers to many of the live attendee questions in a PDF handout. Anyone with full access to the video can log in to download the file.

April 2025 Update

On March 31, 2025, the Eastern District of Texas vacated the FDA’s Final Rule that intended to regulate LDTs as medical devices similar to in vitro diagnostic (IVD) tests, which are commercially manufactured and undergo pre-market review by FDA. At the time of this update, it is still possible that FDA could appeal the decision to halt plans for laboratories to comply with the Final Rule and the deadline to implement certain features of FDA’s medical device quality system regulations by May 6, 2025. It is still to be determined if the FDA will seek to appeal the decision, however.

The AST Education Committee would like to thank the AST TxDx COP for suggesting this topic as part of the 2024-2025 Timely Topics in Transplantation (T3) webinar series.