FDA LDT final rule implementation fact sheet

The FDA ruling on LDTs went into effect May 2024 and the requirements will be phased in stages beginning May 2025 through May 2028.

CLSI is committed to providing guidance, tools and resources to help laboratories meet the new FDA LDT requirements. In a close working relationship with laboratory professionals, CLSI understands that there is uncertainty around meeting these requirements – this LDT Fact Sheet is a first step toward addressing those questions and gaining a sense of control over a changing regulatory environment.

This factsheet is shared as part of the global #CLINICAL24 conversation