All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance.

Key Features

  • Addresses global regulations and regulatory issues surrounding biomaterials and medical devices
  • Especially useful for smaller companies who may not employ a full time vigilance professional
  • Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing


Regulatory managers within industry and academia; Entrepreneurs in the field

Table of Contents

  • List of contributors
  • Woodhead Publishing Series in Biomaterials
  • 1. Biomaterials and their applications in medicine
    • Abstract
    • 1.1 Biomaterials – progression of the definition
    • 1.2 The history and future of biomaterials
    • 1.3 Types of biomaterials
    • 1.4 The major factors contributing to specific biomaterial choices
    • 1.5 Important parameters in the development of biomaterials and associated products
    • 1.6 Applications of biomaterials
  • 2. Technical considerations for commercialization of biomaterials
    • Abstract
    • 2.1 Introduction
    • 2.2 General considerations
    • 2.3 Regulation of risks associated with medical products
    • 2.4 Ensuring the safety of medical products
    • 2.5 Demonstrating the efficacy of biomaterials
    • 2.6 Specific product scenarios
    • 2.7 Biologically derived materials
    • 2.8 Understanding and complying with FDA guidelines
    • 2.9 Conclusion
  • 3. Regulatory strategies for biomaterials and medical devices in the USA: classification, design, and risk analysis
    • Abstract
    • 3.1 Food and Drug Administration (FDA) regulatory categorizations and structure
    • 3.2 FDA classification of medical devices
    • 3.3 FDA Quality Systems Regulations (QSR) for medical device and biomaterial design control
    • 3.4 Medical device and biomaterial risk analysis
    • 3.5 Procurement and related processes
  • 4. Clinical development and endpoint strategies for biomaterials and medical devices
    • Abstract
    • 4.1 Food and Drug Administration (FDA) regulatory considerations for biomaterials
    • 4.2 Clinical development pathways for device-based classification
    • 4.3 Testing considerations for biomaterials clinical evaluation
    • 4.4 Clinical development pathways for biologic-based classification
    • 4.5 Clinical de


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© 2015
Woodhead Publishing
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About the editors

Stephen F. Amato

Dr Amato teaches at Northeastern University, is a senior lecturer at Boston College and serves on the board of directors for several organizations, including BioSignostix, the Medical Development Group (MDG) and the Association of Graduate Regulatory Educators (AGRE). His research has been extensively published and he has presented on regulatory affairs across the United States, China and India.