GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination

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Good Clinical Practices (GCP) Regulations for Medical Devices

US FDA Title 21 CFR Parts

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
















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