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Fundamentals of Medical Device Regulations, Fifth Edition, is a compilation encompassing completely revised medical device and in vitro diagnostic (IVD) chapters from Fundamentals of US Regulatory Affairs, 11th Edition, and Fundamentals of EU Regulatory Affairs, Ninth Edition, in addition to the medical device and IVD chapters from Fundamentals of International Regulatory Affairs, Fifth Edition, updated in June 2021.

In addition to a current view of regulations governing medical devices and IVDs, global experts have provided related content on combination products; regulatory strategy; advertising and promotion; enforcement and competent authorities; FDA communications, meetings, and user fees; current good manufacturing practices; quality system design; preclinical testing; clinical evaluation; and clinical investigations. This book covers the entire medical device lifecycle, from product development through postmarketing and is an excellent resource for finding answers to medical device questions and learning more about the industry.

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Studying for the RAC?

RAC Exam questions are updated after the Spring testing cycle every year to reflect current regulations, guidelines and practice. New examination content is added before the Summer testing cycle and covers regulations in effect as of 31 December of the previous year.