The FDA released its final guidance document: “Laboratory Developed Tests (LDTs): Small Entity Compliance Guide”

This guide helps small entities navigate the new regulatory landscape for LDTs, as outlined in the recent LDT Final Rule.

The rule clarifies that LDTs fall under the FDA’s oversight, ensuring patient safety and test accuracy.

Find out more about our LDTs expertise at: https://lnkd.in/dreiWTp7