Medical Devices; Class II Special Controls Guidance Document; Cyclosporine and Tacrolimus Assays; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Class II Special Controls Guidance Document; Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA." These assays are used as an aid in the management of transplant patients receiving these drugs. Elsewhere in this issue of the Federal Register, FDA is issuing a final rule to reclassify cyclosporine and tacrolimus assays into class II (special controls).