Regulatory Affairs for Biomaterials and Medical Devices.

Cover -- Regulatory Affairs for Biomaterials and Medical Devices -- Copyright -- Contents -- List of contributors -- Woodhead Publishing Series in Biomaterials -- 1 Biomaterials and their applications in medicine -- 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 -- 1.7 Sources of further information and advice -- References -- 2 Technical considerations for commercialization of biomaterials -- 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 -- References -- 3 Regulatory strategies for biomaterials and medical devices in the USA: classification, design, and risk analysis -- 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 -- References -- 4 Clinical development and endpoint strategies for biomaterials and medical devices -- 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 -- Appendix 1: Applicable FDA guidance documents and ASTM standards for biomaterials -- Appendix 2: Applicable FDA product codes and target areas for Class II biomaterials -- 5 The clinical evaluation and approval threshold of biomaterials and medical devices -- 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 -- References -- 6 Supply chain controls for biomaterials and medical devices in the USA -- 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 -- 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 -- 7.7 Sources of further information and advice -- 8 Good manufacturing practice (GMP) for biomaterials and medical devices in the EU and the USA -- 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 -- 8.11 Sources of further information -- Bibilography -- 9 Postmarket surveillance approaches for biomaterials and medical devices in the USA -- 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 -- References -- 10 Fundamentals of medical device approval in the Asia Pacific region -- 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 -- References -- Appendix: glossary of terms -- Index.

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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.