Medical devices; general and plastic surgery devices; classification of tissue adhesive with adjunct wound closure device intended for topical approximation of skin. Final rule.
The Food and Drug Administration (FDA) is classifying the tissue adhesive with adjunct wound closure device intended for topical approximation into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive With Adjunct Wound Closure Device Intended for the Topical Approximation of Skin.'' The agency is classifying the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type.
D018795:Device Approval; D004867:Equipment Design; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D013525:Surgical Instruments / Q000145:classification*; D013529:Surgical Wound Dehiscence / Q000628:therapy; D014014:Tissue Adhesives / Q000145:classification*; D014481:United States; D014486:United States Food and Drug Administration; D014945:Wound Healing
D014014:Tissue Adhesives