Clinical Chemistry and Clinical Toxicology Devices; Reclassification of Cyclosporine and Tacrolimus Assays

The Food and Drug Administration (FDA) is reclassifying cyclosporine and tacrolimus assays from class III (premarket approval) to class II (special controls). These assays are used as an aid in the management of transplant patients receiving these drugs. FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA" as the special control the agency believes will reasonably ensure the safety and effectiveness of these devices. This reclassification is being taken after a review of petitions submitted by Dade Behring, Inc., and Microgenics, Inc. The agency is taking this action under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA."