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FDA Classifies Tissue Adhesive into Class 2

11/10/2010

Federal Register Final rule: FDA is classifying the tissue adhesive with adjunct wound closure device intended for topical approximation into Class 2 (special controls). The agency is also making a guidance document available to serve as the special control, 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. To view this final rule, click here.

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