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