The U.S. Food and Drug Administration recently explained the regulatory obligations of laboratories for laboratory-developed tests (LDTs) under new regulations set to take effect May 6, 2025.
The College of American Pathologists raised this issue to the FDA following questions from pathologists and laboratories about how to classify the tests, what documentation is needed, and whether laboratories can bring those test systems online now. In its response, the FDA stipulated that it classifies all in vitro diagnostics (IVDs) manufactured by laboratories — including LDTs — the same way it regulates other IVD systems, according to “the intended use and risk of the test system.”
The FDA recommends an IVD manufacturer use the product classification database to determine the classification of a device type that has previously been classified by the FDA. The FDA 510(k), Premarket Approval (PMA), and De Novo databases are also helpful resources for finding information about how specific IVDs are regulated.
Those IVDs not already classified by the FDA are automatically Class III. Manufacturers should assess the risk of the IVD and submit appropriate premarket submission, with high-risk tests likely needing a PMA. Any low- or moderate-risk tests may be eligible for de novo classification.
More information about LDT oversight can be found on the FAQ page or by emailing ldtfinalrule@fda.hhs.gov with specific questions.
Source:
https://www.cap.org/advocacy/latest-news-and-practice-data/november-26-2024#story5
