US FDA perspective on the regulations of medical-grade polymers: cyanoacrylate polymer medical device tissue adhesives.
This article provides a brief description of the uses and clinical applications of medical-grade polymers, in particular synthetic cyanoacrylate adhesive/glue devices that have been cleared and/or approved as medical devices by the US FDA since the Medical Device Amendments of 1976 were enacted. This includes Class I cyanoacrylate devices (e.g., liquid bandages), Class II cyanoacrylate devices (e.g., dental cements), and Class III (premarket approval) cyanoacrylate devices such as Dermabond, Indermil Tissue Adhesive, Histoacryl and Histoacryl Blue Topical Skin Adhesive, and Trufill n-Butyl Cyanoacrylate Embolic Agent. By citing an example of FDA approved Class III devices in the cyanoacrylate technology, the article 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 investigational device exception applications and in the development of valid scientific evidence to support premarket approval applications for cyanocrylate tissue adhesives intended for topical approximation of skin and others. The article provides a short regulatory description of the US FDA; under what laws its operates, how the 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.
Mattamal
George J
GJ
US Food and Drug Administration, Division of General, Restorative, and Neurological Devices, Office of Device Evaluation, Center for Devices & Radiological Health, Rockville, MD 20850, USA. george.mattamal@fda.hhs.gov
D003487:Cyanoacrylates / Q000737:chemistry*; D004864:Equipment and Supplies; D033161:Government Regulation; D006801:Humans; D008389:Marketing of Health Services / Q000331:legislation & jurisprudence; D008422:Materials Testing; D011108:Polymers / Q000737:chemistry*; D014014:Tissue Adhesives / Q000737:chemistry*; D014481:United States; D014486:United States Food and Drug Administration
D003487:Cyanoacrylates; D011108:Polymers; D014014:Tissue Adhesives