Four Strategic Questions About the Future of Diagnostics in the Wake of FDA’s Final Rule on Laboratory Developed Tests

Lexology April 29, 2024
Sidley Austin LLP

Having received more than 6,500 comments on the proposed rule released in October 2023, the U.S. Food and Drug Administration (FDA) has now finalized an effort to extend medical device requirements to laboratory developed tests (LDTs).¹ In short, the final rule on this topic adds a single sentence to FDA regulations governing in vitro diagnostic products (IVDs), which will now state that all IVDs are devices, “including when the manufacturer … is a laboratory.”²

The preamble to the final rule is massive (over 500 pages in its prepublication form) and includes a complex discussion of the ways in which FDA expects laboratories to come into compliance with the device requirements. This includes discussion of many specific types of LDTs that,...

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