Book 2-FDAE6R3: 2025 Selected Regulations and Guidance for Medical Device Studies (With FDA/ICH GCP E6 (R3))Description Contents Cover This spiral bound, 5" x 7. 5" book is a compilation of the FDA regulations and guidance documents that govern medical device research. It includes such topics as: Good Clinical Practice Protection of Human Subjects Premarket Notification (510(k)) Submissions Electronic Records and Signatures Monitoring and Reporting Adverse Events Who Uses this Book and How? Medical device research staff, as job aids Training departments, as