FDA-CDRH Medical Device Manufacturing and Regulation Handbook

The Medical Device Regulation provides the current thinking of the FDA-CDRH on the regulation of medical devices. This well-structured reference tool offers practical information to help medical device manufacturers, both within and outside the United States, with premarket applications and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field, written by an author with expertise in regulatory affairs and the commercialization of medical devices.

The content covers how devices meet the criteria for being considered a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and the laws and standards that govern testing. This information is presented in a way that puts regulations in the context of contemporary design, making it accessible and relevant to the reader.

Notably, the book offers a unique focus on the regulatory affairs industry, specifically targeting regulatory affairs professionals and those seeking certification. It includes case studies and applications of regulations, providing practical examples to illustrate the concepts discussed.

Overall, this reference tool is a valuable resource for medical device manufacturers, regulatory affairs professionals, and those seeking a deeper understanding of the regulatory landscape in the medical device industry. The well-structured and comprehensive approach, combined with the author's expertise, ensures that readers can navigate the complex regulatory requirements with confidence.

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