Good Clinical Practice – Medical Device

Good Clinical Practices (GCP) Regulations for Medical Devices 
21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA 

21 CFR and ICH Parts:

• 11 - Electronic Records; Electronic Signatures
  
• 50 - Protection of Human Subjects
  
• 54 - Financial Disclosure by Clinical Investigators
  
• 56 - Institutional Review Boards
  
• 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
  
• 812 - Investigational Device Exemptions
  
• 814 - Premarket Approval of Medical Devices
  
• 820 - Quality Systems Regulations
  
• The 510k & Premarket Approval (PMA) Guidance Document