REGULATORY PERSPECTIVE ON CHARACTERIZATION AND TESTING OF ORTHOPEDIC BONE CEMENTS

This paper provides a general regulatory background of acrylic bone ce ments, chemical composition information on several commercially availa ble bone cements, physical and chemical methods of analyses, mechanica l test methods, and risks and failure mechanisms of acrylic bone cemen ts. Suggestions and recommendations presented in Tables 2 and 3 are no t mandatory requirements but reflect data and methodologies which the FDA's Orthopedic Devices Branch (ORDB) believes to be acceptable to ev aluate most pre-clinical data. FDA may require information in addition to that contained in this paper. In some instances, a sponsor may be able to sufficiently justify the omission of some tests. Although this paper describes certain administrative requirements, it does not take the place of the requirements contained in Title 21 of the Code of Fe deral Regulations (21 CFR) Parts 801, 807, 812, and 814 or those found in the statute. (C) 1998 Elsevier Science Ltd. All rights reserved.