Details

Autor(en) / Beteiligte

• Amato, Stephen F.,
• Ezzell, Robert M.,
• Amato, S. F.,

Titel

Regulatory affairs for biomaterials and medical devices

Auflage

1st edition

Ort / Verlag

Cambridge, England : Woodhead Publishing,

Erscheinungsjahr

2015

Link zum Volltext

• Elsevier Books AutoHoldings

Beschreibungen/Notizen

• Description based upon print version of record.
• Includes bibliographical references at the end of each chapters and index.
• 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 biomaterials2.1 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 structure3.2 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 biomaterialsand 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 evaluation4.4 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 biomaterialsand medical devices
• 5.1 The clinical evaluation of biomaterials and medical devices5.2 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
• 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.Addresses global regulations and regulatory issues surrounding biomaterials and medical devicesEspecially useful for smaller companies who may not emplo
• English
• Description based on print version record.