U.S. FDA Perspective on the Regulation of Cyanoacrylate Polymer Tissue Adhesives in Clinical Applications

Abstract

A brief description of the uses and clinical applications of synthetic cyanoacrylate polymer adhesive/glues that have been cleared and/or approved as medical devices by FDA since the Medical Device Amendments of 1976 were enacted. This includes cyanoacrylate Class I devices (Exempt and not Exempt devices), Class II cyanoacrylate devices such as Dental Cements and Orthodontic Bracket Adhesives, and Class III (PMA) devices such as Dermabond™, Indermil™ Tissue Adhesive, and Trufill® n-Butyl Cyanoacrylate Embolic Agent. By citing an example of recently FDA approved Class III (PMA) devices in the Cyanoacrylate technology, the author provides a brief discussion of the FDA approval process of medical devices. It includes the FDA issues regarding the published guidance document for "Cyanoacrylate Topical Tissue Adhesives" that will provide guidance to regulatory personnel and manufacturers in the preparation of IDE applications and in the development of valid scientific evidence to support PMA applications for cyanocrylate tissue adhesives intended for topical approximation of skin and others. Also, the author provides a short regulatory description of US FDA; under what laws its operates, how FDA evaluates new devices for marketing, and how the device regulatory system works, for example, Class I, Class II, and Class III cyanoacrylate medical devices.