Medical Device Clinical with EU Directive

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(R3) Good Clinical Practice

Includes EU Clinical Trial Directive