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Friday, August 27, 2004 - 8:30 AM
SES 9A.1

Lead Presentation: U.S. FDA Perspective on the Regulations on Medical Device Tissue Adhesive Materials such as Cyanoacrylate Adhesives in Clinical Applications

G. J. Mattamal, Office of Device Evaluation, Center for Devices & Radiological Health, Rockville, MD

A brief description of the uses and clinical applications of synthetic cyanoacrylate polymer adhesive/glues devices that have been cleared and/or approved by FDA over the last 15 years. 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, 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 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 adhesive materials intended for topical approximation of skin and others. Also, the author provides a short regulatory description of US FDA; under what laws its operates, the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), how FDA evaluates new devices for marketing, and how the device regulatory system works, as Class I, Class II, and Class III devices.