General and plastic surgery devices; reclassification of the tissue adhesive for topical approximation of skin device. Final rule.
The Food and Drug Administration (FDA) is reclassifying the device type, tissue adhesive for the topical approximation of skin, from class III (premarket approval) into class II (special controls). Tissue adhesives for non-topical uses remain in class III and continue to require premarket approval applications (PMAs). FDA is proposing this reclassification in accordance with the Federal Food, Drug, and Cosmetic Act (the act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin" that will serve as the special control for the reclassified device type.
D000287:Administration, Topical; D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D007880:Legislation, Drug; D019651:Plastic Surgery Procedures / Q000295:instrumentation / Q000331:legislation & jurisprudence; D014014:Tissue Adhesives / Q000009:adverse effects / Q000145:classification*; D014481:United States; D014486:United States Food and Drug Administration
D014014:Tissue Adhesives