Regulatory Affairs for Biomaterials and Medical Devices

Table of contents

1. Cover
2. Regulatory Affairs for Biomaterials and Medical Devices
3. Copyright
4. Contents
5. List of contributors
6. Woodhead Publishing Series in Biomaterials (1/2)
7. Woodhead Publishing Series in Biomaterials (2/2)
8. 1 Biomaterials and their applications in medicine
   1. 1.1 Biomaterials – progression of the definition
   2. 1.2 The history and future of biomaterials
   3. 1.3 Types of biomaterials
   4. 1.4 The major factors contributing to specific biomaterial choices
   5. 1.5 Important parameters in the development of biomaterials and associated products
   6. 1.6 Applications of biomaterials
   7. 1.7 Sources of further information and advice
   8. References
9. 2 Technical considerations for commercialization of biomaterials
   1. 2.1 Introduction
   2. 2.2 General considerations
   3. 2.3 Regulation of risks associated with medical products
   4. 2.4 Ensuring the safety of medical products
   5. 2.5 Demonstrating the efficacy of biomaterials
   6. 2.6 Specific product scenarios
   7. 2.7 Biologically derived materials
   8. 2.8 Understanding and complying with FDA guidelines
   9. 2.9 Conclusion
   10. References
10. 3 Regulatory strategies for biomaterials and medical devices in the USA: classification, design, and risk analysis
    1. 3.1 Food and Drug Administration (FDA) regulatory categorizations and structure
    2. 3.2 FDA classification of medical devices
    3. 3.3 FDA Quality Systems Regulations (QSR) for medical device and biomaterial design control
    4. 3.4 Medical device and biomaterial risk analysis
    5. 3.5 Procurement and related processes
    6. References
11. 4 Clinical development and endpoint strategies for biomaterials and medical devices
    1. 4.1 Food and Drug Administration (FDA) regulatory considerations for biomaterials
    2. 4.2 Clinical development pathways for device-based classification
    3. 4.3 Testing considerations for biomaterials clinical evaluation
    4. 4.4 Clinical development pathways for biologic-based classification
    5. 4.5 Clinical development pathways for combination product classification
    6. 4.6 Clinical development elements required in biomaterials product evaluation in all regulatory pathways
    7. Appendix 1: Applicable FDA guidance documents and ASTM standards for biomaterials
    8. Appendix 2: Applicable FDA product codes and target areas for Class II biomaterials
12. 5 The clinical evaluation and approval threshold of biomaterials and medical devices
    1. 5.1 The clinical evaluation of biomaterials and medical devices
    2. 5.2 Geographical differences in clinical evaluations
    3. 5.3 Clinical quality assurance
    4. 5.4 Threshold for approval
    5. 5.5 The current regulatory landscape
    6. 5.6 Future trends
    7. References
13. 6 Supply chain controls for biomaterials and medical devices in the USA
    1. 6.1 Introduction
    2. 6.2 Overview of supply chain risks and mitigating activities
    3. 6.3 Product distribution: traditional and emerging risks
    4. 6.4 Counterfeit challenges
    5. 6.5 Challenges relating to recalls, imports and environmental management
    6. 6.6 Risk management system
    7. 6.7 Regulatory risks affecting sponsor oversight of a supplier
    8. 6.8 Supplier risks in the supply chain
    9. 6.9 Supplier impact on product risk
    10. 6.10 Product liability risks and the supply chain
    11. 6.11 Summary
14. 7 Global marketing authorisation of biomaterials and medical devices
    1. 7.1 Introduction
    2. 7.2 Placing devices on the EU market
    3. 7.3 Placing devices on the US market
    4. 7.4 Placing devices on the Australian market
    5. 7.5 Placing devices on the Canadian market
    6. 7.6 Future trends
    7. 7.7 Sources of further information and advice
15. 8 Good manufacturing practice (GMP) for biomaterials and medical devices in the EU and the USA
    1. 8.1 Introduction
    2. 8.2 History of GMP
    3. 8.3 The essential rules of GMP
    4. 8.4 Global overview on GMP
    5. 8.5 GMP and management
    6. 8.6 Requirements of a GMP quality system: prior to routine production (1/2)
    7. 8.6 Requirements of a GMP quality system: prior to routine production (2/2)
    8. 8.7 Requirements of a GMP quality system: preparing and performing routine production
    9. 8.8 Particular aspects of ‘EU GMP’ and comparison with 21 CFR Part 820
    10. 8.9 GMP and product life span (1/2)
    11. 8.9 GMP and product life span (2/2)
    12. 8.10 Future trends for GMP
    13. 8.11 Sources of further information
    14. Bibilography
16. 9 Postmarket surveillance approaches for biomaterials and medical devices in the USA
    1. 9.1 Classification-based postmarketing surveillance pathway
    2. 9.2 Postmarketing surveillance pathway for device-based classification
    3. 9.3 Postmarketing surveillance pathway for biologics-based classification
    4. 9.4 Postmarketing surveillance pathway for combination-based classification
    5. 9.5 Strengthening postmarket surveillance
    6. References
17. 10 Fundamentals of medical device approval in the Asia Pacific region
    1. 10.1 Introduction
    2. 10.2 Asia Pacific regulatory environment – good practice
    3. 10.3 Defining the regulatory strategy in the Asia Pacific region
    4. 10.4 Scheduling medical device registrations in the Asia Pacific region (reducing registration lead time)
    5. 10.5 Follow-up of the device registration
    6. 10.6 Conclusion
    7. References
    8. Appendix: glossary of terms
18. Index (1/3)
19. Index (2/3)
20. Index (3/3)