Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook

The Medical Device Regulation provides an overview of the regulation of medical devices, including criteria for being a medical device, regulatory agencies, marketing rules devices, and testing laws and standards. It is a practical reference tool for manufacturers, helping them with premarket applications and meeting complex FDA regulatory requirements.

Format: Paperback / softback
Length: 678 pages
Publication date: 24 February 2023
Publisher: Elsevier Science & Technology

The Medical Device Regulation provides a comprehensive overview of the current FDA-CDRH thinking on the regulation of medical devices. This invaluable resource offers a wealth of information on the criteria for determining whether a device qualifies as a medical device, the agencies responsible for regulating these devices, the impact of regulatory policies on the market, marketing regulations, and the laws and standards governing testing. Designed as a practical and well-structured reference tool, this book is particularly valuable for medical device manufacturers, both within and outside the United States, who are navigating the complex premarket application process and meeting stringent FDA regulatory requirements. Authored by an expert in regulatory affairs and commercialization of medical devices, the book provides a comprehensive perspective on the field, covering key topics such as device classification, design and development, manufacturing, labeling, and post-market surveillance. By leveraging the expertise and insights of the author, readers can gain a deep understanding of the regulatory landscape and develop effective strategies for ensuring the safety and efficacy of their medical devices. Whether you are a seasoned professional in the medical device industry or just starting your journey, The Medical Device Regulation is an essential resource that will help you stay informed, compliant, and competitive in this rapidly evolving field.

Weight: 450g
Dimension: 235 x 191 (mm)
ISBN-13: 9780323953542