LDTs: The Saga ContinuesMay 14, 2017
Over its ten years the FDA Law Blog has posted numerous stories about FDA's regulation of laboratory developed tests (LDTs) (see, e.g., here, here, and here) Yet, the story of FDA's efforts to regulate LDTs goes back even further than the FDA Law Blog, to 1992. While there have been other regulatory initiatives that have lasted longer – the OTC review, DESI review, and the program to end Class III 510(k) devices spring to mind– the 25 year LDT saga has had a healthy run.
Hyman, Phelps & McNamara, P.C. Director Jeff Gibbs recently published in the FDLI Update an article that summarizes this 25-year history. The article, titled "LDTs: The Saga Continues," summarizes the tale of LDT regulation, from FDA's initial statement of authority through developing a plan to regulate to LDTs, culminating in FDA's issuance of a Discussion Draft about how LDTs might someday be regulated in the future. For devotees of LDTs – or of epic efforts to regulate a class of products – it will be riveting reading. And for those who have not read about laboratory developed tests before, and never thought about them, this succinct summary is the one to read.