Regulatory Affairs for Biomaterials and Medical Devices

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