FDA Clearance An Integrated Clinical, Engineering, and Business Approach

This book provides a comprehensive overview of FDA (Federal Drug Administration) procedures. It simplifies the complexities involved in getting FDA clearance by using an integrated approach of clinical, engineering, and business aspects. It includes both medical devices and drug development. This involves understanding the structure of the FDA, its purpose, and its initiatives. This book also examines what is needed for designing clinical trials and addressing recalls and failures. It uses case studies to further illustrate the integrated method stressed throughout this work.

PART 1: Overview Introduction: Overview of the FDA, [Dr. Gurman, Dr. Rosen, Dr. Elman] PART 2: Clinical Considerations Understanding Clinical Trials for Drugs and Devices with Case studies [Dr. Gurman] Designing Clinical Trials for FDA [Clinical Trials Consulting Group TBD] Simplifying the process of FDA submission and clearance Interacting with the FDA [FDA consulting group, TBD] Recalls and Failures Patient Safety and Satisfaction [Dr. Ronen Rozenblum et al, Unit of Patient Satisfaction, Safety, Brigham Women’s Hospital, Harvard Medical School) PART 3: Technological Considerations FDA and other regulatory requirements [Dr. Willie Foerstener et al, Medical Device Consultant] PART 4: Industry and Business Considerations Capital Challenges Technology Transition [Dolphin Consulting Group, Dr. Steve Jarret] Business Transformations for FDA Clearance PART 5: Appendix and FDA Reference for Cleared Biomedical and Biomaterials Appendix and FDA Reference (Dr. Gurman)