How FDA’s New Rule on LDTs Impacts Medical Device Companies and Labs
On May 6, 2024, the U.S. Food and Drug Administration (FDA) issued a final rule that significantly modified its approach to overseeing laboratory developed tests (LDTs). This rule, which became effective on July 5, 2024, marks a pivotal change for companies producing LDTs. The new regulations aim to ensure that these tests meet the same […]