Successfully integrating the FDA regulations into your practice

Abstract

The fertility field has had its challenges with regard to state and federal regulations over the past 20 years. In 2005, ART programs were faced with a new regulatory challenge - the Food and Drug Administration. The ruling entitled 21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products regulates non-vascularized human tissues including reproductive tissues and touches on donor and non-donor tissues affecting the clinical, as well as the laboratory areas of an ART program. This chapter examines the history of ART regulation, defines the scope of what is regulated for ART programs, and describes the most important aspects of the ruling that medical and laboratory directors need to know for compliance. In addition, practical field-tested information from a fertility perspective is given on how to develop and maintain a compliance program specifically focused on dealing with the 21 CFR Part 1271 ruling. Finally, case examples from real donor situations are described in order to test the reader's knowledge and comprehension of the regulations as applied to an ART program. © Springer Science+Business Media, LLC 2010.