Regulatory Affairs for Biomaterials and Medical Devices

Regulatory Affairs for Biomaterials and Medical Devices

1st Edition - April 7, 2014

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  • Editors: S Amato, B Ezzell
  • Hardcover ISBN: 9780857095428
  • eBook ISBN: 9780857099204

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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

  • 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 development pathways for combination product classification
    • 4.6 Clinical development elements required in biomaterials product evaluation in all regulatory pathways

    5. The clinical evaluation and approval threshold of biomaterials and medical devices

    • Abstract
    • 5.1 The clinical evaluation of biomaterials and medical devices
    • 5.2 Geographical differences in clinical evaluations
    • 5.3 Clinical quality assurance
    • 5.4 Threshold for approval
    • 5.5 The current regulatory landscape
    • 5.6 Future trends

    6. Supply chain controls for biomaterials and medical devices in the USA

    • Abstract
    • 6.1 Introduction
    • 6.2 Overview of supply chain risks and mitigating activities
    • 6.3 Product distribution: traditional and emerging risks
    • 6.4 Counterfeit challenges
    • 6.5 Challenges relating to recalls, imports and environmental management
    • 6.6 Risk management system
    • 6.7 Regulatory risks affecting sponsor oversight of a supplier
    • 6.8 Supplier risks in the supply chain
    • 6.9 Supplier impact on product risk
    • 6.10 Product liability risks and the supply chain
    • 6.11 Summary

    7. Global marketing authorisation of biomaterials and medical devices

    • Abstract
    • 7.1 Introduction
    • 7.2 Placing devices on the EU market
    • 7.3 Placing devices on the US market
    • 7.4 Placing devices on the Australian market
    • 7.5 Placing devices on the Canadian market
    • 7.6 Future trends

    8. Good manufacturing practice (GMP) for biomaterials and medical devices in the EU and the USA

    • Abstract
    • 8.1 Introduction
    • 8.2 History of GMP
    • 8.3 The essential rules of GMP
    • 8.4 Global overview on GMP
    • 8.5 GMP and management
    • 8.6 Requirements of a GMP quality system: prior to routine production
    • 8.7 Requirements of a GMP quality system: preparing and performing routine production
    • 8.8 Particular aspects of ‘EU GMP’ and comparison with 21 CFR Part 820
    • 8.9 GMP and product life span
    • 8.10 Future trends for GMP

    9. Postmarket surveillance approaches for biomaterials and medical devices in the USA

    • Abstract
    • 9.1 Classification-based postmarketing surveillance pathway
    • 9.2 Postmarketing surveillance pathway for device-based classification
    • 9.3 Postmarketing surveillance pathway for biologics-based classification
    • 9.4 Postmarketing surveillance pathway for combination-based classification
    • 9.5 Strengthening postmarket surveillance

    10. Fundamentals of medical device approval in the Asia Pacific region

    • Abstract
    • 10.1 Introduction
    • 10.2 Asia Pacific regulatory environment – good practice
    • 10.3 Defining the regulatory strategy in the Asia Pacific region
    • 10.4 Scheduling medical device registrations in the Asia Pacific region (reducing registration lead time)
    • 10.5 Follow-up of the device registration
    • 10.6 Conclusion
    • Appendix: glossary of terms

Product details

  • No. of pages: 202
  • Language: English
  • Copyright: © Woodhead Publishing 2014
  • Published: April 7, 2014
  • Imprint: Woodhead Publishing
  • Hardcover ISBN: 9780857095428
  • eBook ISBN: 9780857099204

About the Editors

S 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.

Affiliations and Expertise

Professor at Northeastern University, USA

B Ezzell

Affiliations and Expertise

Northeastern University, USA

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