Regulatory affairs for biomaterials and medical devices

Title:

Series:

Woodhead publishing series in biomaterials ; no. 79

Publication Information:

Philadelphia, PA : Woodhead Pub., 2015

Physical Description:

xv, 185 p. ; 24 cm.

ISBN:

9780857095428

Abstract:

This book provides key information on the regulatory practices and policies relating to biomaterials and medical devices in different regions, particularly Europe, the USA and Asia.

Subject Term:

Biomedical materials

Medical instruments and apparatus -- Safety measures

Added Author:

Amato, Stephen F.

Ezzell, Robert M.

Available:*

Library	Item Barcode	Call Number	Material Type	Item Category 1	Status
Searching... PSZ JB	30000010343096	R856.6 R44 2015	Open Access Book	Book	Searching... Unknown

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.

Author Notes

Dr Stephen F. Amato is a senior member of the Regulatory Affairs and Market Access Faculty at the College of Professional Studies, Northeastern University, Boston, USA. He is a consultant for the Regulatory Affairs Professional Society and has more than 20 years of global experience in the biotechnology and medical device industries. Dr Robert M. Ezzell is a graduate instructor on the Northeastern University Regulatory Affairs Graduate Program.

I. KulinetsN. Scarborough and N. MukherjeeS.F AmatoS. F AmatoK.G. StevensS.F. AmatoJ.J. TobinF. TarabahK. DesaiJ.L. Wong and P. Teysseyre

List of contributors	p. ix
Woodhead Publishing Series in Biomaterials	p. xi
1 Biomaterials and their applications in medicine	p. 1
1.1 Biomaterials - progression of the definition	p. 1
1.2 The history and future of biomaterials	p. 2
1.3 Types of biomaterials	p. 4
1.4 The major factors contributing to specific biomaterial choices	p. 6
1.5 Important parameters in the development of biomaterials and associated products	p. 7
1.6 Applications of biomaterials	p. 8
1.7 Sources of further information and advice	p. 9
References	p. 10
2 Technical considerations for commercialization of biomaterials	p. 11
2.1 Introduction	p. 11
2.2 General considerations	p. 11
2.3 Regulation of risks associated with medical products	p. 12
2.4 Ensuring the safety of medical products	p. 13
2.5 Demonstrating the efficacy of biomaterials	p. 16
2.6 Specific product scenarios	p. 17
2.7 Biologically derived materials	p. 19
2.8 Understanding and complying with FDA guidelines	p. 21
2.9 Conclusion	p. 25
References	p. 25
3 Regulatory strategies for biomaterials and medical devices in the USA: classification, design, and risk analysis	p. 27
3.1 Food and Drug Administration (FDA) regulatory categorizations and structure	p. 27
3.2 FDA classification of medical devices	p. 31
3.3 FDA Quality Systems Regulations (QSRs) for medical device and biomaterial design control	p. 35
3.4 Medical device and biomaterial risk analysis	p. 38
3.5 Procurement and related processes	p. 42
References	p. 44
4 Clinical development and endpoint strategies for biomaterials and medical devices	p. 47
4.1 Food and Drug Administration (FDA) regulatory considerations for biomaterials	p. 47
4.2 Clinical development pathways for device-based classification	p. 48
4.3 Testing considerations for biomaterials clinical evaluation	p. 53
4.4 Clinical development pathways for biologic-based classification	p. 56
4.5 Clinical development pathways for combination product classification	p. 58
4.6 Clinical development elements required in biomaterials product evaluation in all regulatory pathways	p. 59
Appendix 1 Applicable FDA guidance documents and ASTM standards for biomaterials	p. 60
Appendix 2 Applicable FDA product codes and target areas for Class II biomaterials	p. 63
5 The clinical evaluation and approval threshold of biomaterials and medical devices	p. 67
5.1 The clinical evaluation of biomaterials and medical devices	p. 67
5.2 Geographical differences in clinical evaluations	p. 69
5.3 Clinical quality assurance	p. 70
5.4 Threshold for approval	p. 71
5.5 The current regulatory landscape	p. 74
5.6 Future trends	p. 75
References	p. 77
6 Supply chain controls for biomaterials and medical devices in the USA	p. 79
6.1 Introduction	p. 79
6.2 Overview of supply chain risks and mitigating activities	p. 79
6.3 Product distribution: traditional and emerging risks	p. 80
6.4 Counterfeit challenges	p. 82
6.5 Challenges relating to recalls, imports and environmental management	p. 84
6.6 Risk management system	p. 85
6.7 Regulatory risks affecting sponsor oversight of a supplier	p. 87
6.8 Supplier risks in the supply chain	p. 88
6.9 Supplier impact on product risk	p. 89
6.10 Product liability risks and the supply chain	p. 90
6.11 Summary	p. 92
7 Global marketing authorisation of biomaterials and medical devices	p. 93
7.1 Introduction	p. 93
7.2 Placing devices on the EU market	p. 93
7.3 Placing devices on the US market	p. 105
7.4 Placing devices on the Australian market	p. 109
7.5 Placing devices on the Canadian market	p. 109
7.6 Future trends	p. 112
7.7 Sources of further information and advice	p. 113
8 Good manufacturing practice (GMP) for biomaterials and medical devices in the EU and the USA	p. 115
8.1 Introduction	p. 115
8.2 History of GMP	p. 116
8.3 The essential rules of GMP	p. 117
8.4 Global overview on GMP	p. 120
8.5 GMP and management	p. 121
8.6 Requirements of a GMP quality system: prior to routine production	p. 126
8.7 Requirements of a GMP quality system: preparing and performing routine production	p. 132
8.8 Particular aspects of 'EU GMP" and comparison with 21 CFR Part 820	p. 134
8.9 GMP and product life span	p. 135
8.10 Future trends for GMP	p. 142
8.11 Sources of further information	p. 143
Bibliography	p. 143
9 Postmarket surveillance approaches for biomaterials and medical devices in the USA	p. 145
9.1 Classification-based postmarketing surveillance pathway	p. 145
9.2 Postmarketing surveillance pathway for device-based classification	p. 145
9.3 Postmarketing surveillance pathway for biologies-based classification	p. 152
9.4 Postmarketing surveillance pathway for combination-based classification	p. 154
9.5 Strengthening postmarket surveillance	p. 155
References	p. 157
10 Fundamentals of medical device approval in the Asia Pacific region	p. 159
10.1 Introduction	p. 159
10.2 Asia Pacific regulatory environment - good practice	p. 160
10.3 Defining the regulatory strategy in the Asia Pacific region	p. 164
10.4 Scheduling medical device registrations in the Asia Pacific region (reducing registration lead time)	p. 166
10.5 Follow-up of the device registration	p. 170
10.6 Conclusion	p. 172
References	p. 173
Appendix: glossary of terms	p. 173
Index	p. 175

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Table of Contents