CEO SUMMARY: 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 […]
What Labs with LDTs Must Do to Comply with FDA’s LDT Rule
Compliance with LDT Rule will be time-consuming and costly for majority of LDTs
- By Robert Michel
- > From the Volume XXXI, No. 10 - July 22, 2024 Issue
- Tags: Department of Defense, FDA, Food and Drug Administration, high risk test, in vitro diagnostics, IVD, ivd/lab informatics, Jane Pine Wood JD, laboratory-developed test, ldt, LDT rule, low risk test, mandatory onsite inspections, McDonald Hopkins, medical device reporting, moderate risk test, New York State Clinical Laboratory Evaluation Program, NYS CLEP, premarket application submissions, premarket review, VA, Veterans Health Administration
