Safety Evaluation in the Development of Medical Devices and Combination Products (Hardcover, 3)

1. Introduction. I. Biocompatibility. II. Scope of Devices and the Medical Device Market. III. History. IV. Regulatory Considerations for NGO’s and Secondary Regulators. 2. Regulatory Aspects and Strategies in Medical Device and Biomaterials Safety Evaluation. I. Regulatory Basis. II. Toxicity Testing: Medical Devices. 3. Road Map to Test Selections. I. Key concepts. II. Conditions of use. III. Materials, components, and products. IV. Prior knowledge. V. Types and Uses of Tests. 4. Materials in Medical Device Design. I. Introduction. II. Metals. III. Ceramics. IV. Polymers. V. Nanomaterials. 5. What to Test: Sampling and Sample Preparation. I. Sampling. II. Randomization. III. Sample Preparation. IV. Reference Materials. V. Conclusion. 6. Cytotoxicity Testing. I. Background. II. Cytotoxicity assays. III. Conclusion. 7. Hematocompatibiity. I. Introduction. II. Standard tests. III. Interpretation. IV. Specific Concern. V. Conclusion. 8. Local Tissue Tolerance. I. Dermal irritation. II. Ocular irritation testing. III. Other Nonparenteral Route Irritation Tests. IV. Parenteral Irritation/Tolerance. V. Parental Routes. VI. Intracutaneous Irritation. VII. Pyrogenicity. VIII. Problems in Testing (and Their Resolutions). 9. Immunotoxicology. I. Overview of the Immune System. II. Evaluation of the Immune System. III. Local Lymph Node Assay. III. Approaches. IV. Problems and Future Directions. 10. Implantation Biology and Studies. I. USP implantation Test. II. ISO 10993 Implantation Test. III. Test Method for Implantation in Subcutaneous Tissue. IV. Test Method for Implantation in Muscle. V. Test Method for Implantation in Bone. VI. Controls Materials. VII. Long-term Implant Studies. VIII. Considerations. 11. Acute Systemic Testing. 12. Genotoxicity. I. DNA structure. II. Mutagenicity. III. Cytogenetics. IV. In Vitro Cytogenetic Assays. V. In Vivo Cytogenetic Assays. VI. Sister Chromatid Exchange Assays. 13. Subchronic and Chronic Toxicity and Reproductive and Developmental Toxicity. I. Objectives. II. Regulatory considerations. III. Parameters to measure. IV. Histopathology. V. Study Interpretation and Reporting. VI. Reproductive and Developmental Toxicity. 14. Carcinogenicity. I. Animal models. II. Dose Selection. III. Interpretation of Results. 15. Degradation Products and Impurties. I. Introduction. II. Metals. III. Ceramics & Glasses. IV. Polymers. V. Effects of Sterilization. VI. Heavy Metals. 16. Combination Products. I.Combination Products. II. Principal Mode of Action (PMOA). III. Testing to serve two or more Regulatory Masters. 17. Clinical Studies for Medical Devices. I. Design considerations. II. Epidemiology. III. Conclusion. 18. Special Studies. I. Cardiovascular Devices and Prostheses. II. Tampons. III. Contact Lenses and Their Solutions. IV. Thrombogenicity. V. Twenty-One-Day Eye Irritation Study in Rabbits. VI. Systemic Injection Test. VII. Production of Toxic Shock Syndrome Toxin-1 (TSST-1). VIII. In Vitro Evaluation of the Effects of Potential Tampon Materials on PH And Growth of Vaginal Microflora. IX. Inflammatory Response to Biomaterials. 19. Toxicokinetics 20. Case Histories and Problem Resolution I. DEHP in devices. II. Dalkon Shield. III. Talc on Gloves and Condoms. IV. Toxic Shock Syndrome. V. Latex Allergy. VI. Silicone in Devices. VII. Drug Coded Stents. VIII. Antimicrobial Catheter. IX. Problem Solving. X. Risk Assessments. XI. Conclusion.