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

by Gad; Shayne Cox

• ISBN13: 9781420071641
• ISBN10: 1420071645
• Edition: 3rd
• Format: Hardcover
• Copyright: 2008-10-20
• Publisher: CRC Press

Summary

Still a single-volume practical guide, this third edition of what started as the "Safety Evaluation of Medical Devices" broadens its focus to capture the explosion of advances in the device world. It includes coverage of new materials, novel therapeutic approaches, and the developments in drug/device combination products. The new edition addresses the global nature of device markets and examines each aspect of safety evaluation in terms of ISO, US FDA, EU, MLHW perspectives. In addition to discussions of new regulatory science paradigms, it covers citations and means of access to Internet-based regulatory and scientific sites, reflecting the universal adaptation of this new technology.

Table of Contents

Introduction	p. 1
Regulatory Aspects and Strategy in Medical Device and Bio Materials Safety Evaluation	p. 7
Road Map to Test Selections	p. 27
Materials in Medical Device Design	p. 49
What to Test: Sampling and Sample Preparation	p. 63
Cytotoxicity Testing	p. 69
Hemocompatibility	p. 75
Local Tissue Tolerance	p. 83
Immunotoxicology	p. 99
Implantation Biology and Studies	p. 133
Acute Systemic Toxicity Testing Device Safety Evaluation	p. 143
Genotoxicity	p. 151
Subchronic and Chronic Toxicity and Reproductive and Developmental Toxicity	p. 181
Carcinogenicity	p. 197
Degradation Products and Impurities	p. 203
Combination Products	p. 223
Clinical Studies for Medical Devices	p. 231
Special Studies	p. 243
Toxicokinetics in Biomaterial and Device Safety Evaluation	p. 255
Case Histories and Problem Resolution	p. 275
Selected Regulatory and Toxicological Acronyms and Abbreviations	p. 289
Contract Testing Laboratories	p. 291
Notable International Regulatory Internet Addresses	p. 293
Non-U.S. Medical Device Regulators	p. 295
Index	p. 297
Table of Contents provided by Blackwell. All Rights Reserved.