Safety Evaluation in the Development of Medical Devices and Combination Products, Third Edition

Overview

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field.

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Overview

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field.

The Third Edition explores these key current trends:


  • global device markets
  • continually advancing technology
  • the increasing harmonization of device safety regulation worldwide

Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.

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Product Details

  • ISBN-13: 9780824706173
  • Publisher: Taylor & Francis
  • Publication date: 1/28/2002
  • Edition description: REV
  • Edition number: 2
  • Pages: 504
  • Product dimensions: 6.26 (w) x 9.26 (h) x 1.26 (d)

Meet the Author

SHAYNE C. GAD is the principal of Gad Consulting Services, Cary, North Carolina, USA. Gad Consulting Services is a 15-year-old consulting firm serving more than 350 clients (including 120 pharmaceutical companies in the US and 35 overseas). Dr. Gad received his B.S. in chemistry and biology from Whittier College, Whittier, California, and his Ph.D. in pharmacology and toxicology from the University of Texas at Austin, Austin, Texas, USA. He has published 39 books and more than 350 chapters, articles, and abstracts in the fields of toxicology, statistics, pharmacology, drug development, and safety assessment. Dr. Gad has more than 30 years of broad-based experience in toxicology, drug and device development, statistics, and risk assessment with specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, and genotoxicology. He was the past president of the American College of Toxicology and the Roundtable of Toxicology Consultants. Dr. Gad has consulted for the US Food and Drug Administration, Environmental Protection Agency, and the National Institutes of Health.

MARIAN G. MCCORD is Associate Professor with appointments in the Department of Textile Engineering, Chemistry, and Science at North Carolina State University, Raleigh, NC, USA, the Joint UNC/NCSU Department of Biomedical Engineering in Raleigh and Chapel Hill, NC, USA, and an Adjunct Associate Professor of Medicine at the University of North Carolina at Chapel Hill. She serves as co-Director of the Atmospheric Plasma Laboratory at the College of Textiles at NCSU, and is a leader in development of Advanced Medical Technology at NCSU (www.ncsu.edu/amt). Dr. McCord received her M.S. in Bioengineering and Ph.D. in Textiles and Polymer Science from Clemson University, Clemson, South Carolina, USA. She has been active in several professional organizations, including the AAMI Protective Barriers Committee, ASTM F23, the Biomedical Engineering Society, the American Society for Engineering Education, and the Society for Biomaterials. Dr. McCord is the recipient of the 2007 Richard Felder Award for Outstanding Service in Teaching and Learning. She has been an invited lecturer and presenter at numerous consortia, meetings, and conferences, and has been a valued mentor and advisor for her students.

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Table of Contents

Preface to the Second Edition
Preface to the First Edition
1 Introduction 1
2 Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation 13
3 Road Map to Test Selections 53
4 What to Test: Sampling and Sample Preparation 105
5 Cytotoxicity Testing 117
6 Blood Compatibility 131
7 Irritation and Pyrogenicity 149
8 Immunotoxicology 191
9 Implantation Biology and Studies 269
10 Genotoxicity 295
11 Subchronic and Chronic Toxicity and Reproductive and Developmental Toxicity 363
12 Carcinogenicity 403
13 Sterility, Sterilization, and Heavy Metals 417
14 Combination Devices 431
15 Clinical Studies for Medical Devices 449
16 Special Studies 477
17 Case Histories and Problem Resolution 505
App. A Selected Regulatory and Toxicological Acronyms and Abbreviations 537
App. B Contract Testing Laboratories 541
App. C Notable Regulatory Internet Addresses 543
App. D Non-U.S. Medical Device Regulators 549
Index 551
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