GMP Publications - Code of Federal Regulation Handbooks by the FDA

Medical Device Clinical with EU Directive

MedicalDeviceClinical.EUDirective.jpg
978-1-935131-76-2

US FDA Title 21 CFR Parts

Part 11 - Electronic Records/Electronic Signatures (ERES)
Part 50 - Protection of Human Subjects
Part 54 - Financial Disclosure by Clinical Investigators
Part 56 - Institutional Review Boards
Part 312 - Investigational New Drug Application
Part 812 - Investigational Device Excemptions

International Conference on Harmonisation Regulations

ICH E2A Clinical Safety Data Management
ICH E6(R2) Good Clinical Practice

Includes EU Clinical Trial Directive














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