Federal Register Final rule: FDA is reclassifying the device type, tissue adhesive for the topical approximation of skin, from Class 3 (premarket approval) into Class 2 (special controls). Tissue adhesives for non-topical uses remain in Class 3 and continue to require PMAs. The agency is also making available a guidance document, Class 2 Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin, that will serve as the special control for the reclassified device type. To download this guidance, click here. To view this final rule, click here.