FDA Reclassifies Cyclosporine and Tacrolimus Assays from Class III to Class II for Transplant Patients

Summary

The FDA is reclassifying the use of cyclosporine and tacrolimus assays from a premarket approval requirement to a special control, aiming to ensure the safety and effectiveness of these devices for transplant patients, following a review of petitions from Dade Behring, Inc. and Microgenics, Inc.