Fundamentals of Medical Device Regulations, Fifth Edition

SECTION I: Fundamentals of US Medical Device Regulations
Chapter 1: History of Food, Drug, and Cosmetic Laws
Chapter 2: Regulatory Pathways for Medical Devices and Combination Products
Chapter 3: Clinical Trials: GCPs, Regulations, and Compliance for Drugs, Biologics, and Medical Devices
Chapter 4: FDA Communications and CDRH Meetings
Chapter 5: Current Good Manufacturing Practices and Quality System Design
Chapter 6: FDA User Fees
Chapter 7: Regulatory Strategy
Chapter 8: Medical Device Submissions
Chapter 9: Medical Device Compliance and Postmarketing Activities
Chapter 10: In Vitro Diagnostics Submissions and Compliance
Chapter 11: Labeling, Advertising, and Promotion for Medical Devices and In Vitro Diagnostics
Chapter 12: Combination Products

SECTION II: Fundamentals of EU Medical Device Regulations
Chapter 1: History of EU Regulations
Chapter 2: Enforcement and Competent Authorities
Chapter 3: The New Medical Devices and In Vitro Diagnostic Devices Regulations
Chapter 4: The European Medical Devices Legal System
Chapter 5: Medical Devices: Legislation and Classification
Chapter 6: In Vitro Diagnostic Medical Devices
Chapter 7: General Safety and Performance Requirements and Technical Documentation: EU MDR and EU IVDR
Chapter 8: Medical Device Preclinical Testing
Chapter 9: Clinical Evaluation and Clinical Investigations
Chapter 10: Medical Device Conformity Assessment Procedure
Chapter 11: Medical Device Compliance: Postmarket Requirements
Chapter 12: Medical Device National Particularities
Chapter 13: Combination Products
Chapter 14: Advertising and Promotion
Chapter 15: Regulatory Strategys

SECTION III: Fundamentals of International Medical Device Regulations
Chapter 1: Introduction to International Regulatory Affairs
Chapter 2: Compliance and Enforcement
Chapter 3: International Counterfeit Regulations
Chapter 4: EU Pricing and Reimbursement
Chapter 5: Health Technology Assessment (HTA)
Chapter 6: Medical Device Premarket Requirements
Chapter 7: Technical and Regulatory Requirements
Chapter 8: Medical Device Quality Management Systems
Chapter 9: In Vitro Diagnostic Medical Devices
Chapter 10: Active Implantable Medical Devices
Chapter 11: Software
Chapter 12: Postmarket Requirements
Chapter 13: Combination Products

In addition to a current view of regulations governing medical devices and IVDs, global experts have provided related content on combination products; regulatory strategy; advertising and promotion; enforcement and competent authorities; FDA communications, meetings, and user fees; current good manufacturing practices; quality system design; preclinical testing; clinical evaluation; and clinical investigations. This book covers the entire medical device lifecycle, from product development through postmarketing and is an excellent resource for finding answers to medical device questions and learning more about the industry.