Recent U.S. FDA Reclassification on the Regulation of Tissue Adhesives for Skin Approximation in Clinical Applications

摘要

Since the Medical Device Amendments of 1976 were enacted, the FDA considers Tissue Adhesives as "Transitional Devices" that are classified as Class III medical devices and are marketed in the United States subsequent to the approval of a Pre-market Approval Application (PMA). On February 9, 2006, Regulatory & Clinical Research Institute, Inc. submitted a petition to FDA to reclassify tissue adhesive transitional medical devices for skin approximation from Class III to Class II (special controls). FDA consulted with the General and Plastic Surgery Devices Advisory Panel, and on August 25, 2006, in a public meeting, the panel unanimously recommended that the tissue adhesive transitional medical devices for topical approximation of skin be classified from class III into Class II. Consequently, since June 30, 2008, following the effective date of the FDA Final Rule that reclassified tissue adhesive transitional medical devices for skin approximation, any firm submitting a Premarket Notification [510(k)] for a tissue adhesive for the topical approximation of skin will need to address the issues covered in the published "Class II Special Control Guidance Document: Tissue Adhesive for the Topical Approximation of Skin, dated May 30, 2008". Accordingly, the firm needs to show that its device meets the recommendations of the published Class II guidance document or in some other way provides equivalent assurances of safety and effectiveness. Also, the author provides a short regulatory description of US FDA, under what laws its operates, how FDA evaluates new medical devices for marketing as Class I, Class II, and Class III.