Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This compliance will require substantial staff time and costs that may outweigh the benefit to the lab […]
What Labs with LDTs Must Do to Comply with the FDA’s LDT Rule
Also in the July 22, 2024 issue, a House bill calls for FDA to suspend its new LDT rule
- By Robert Michel
- > From the Volume XXXI, No. 10 - July 22, 2024 Issue
