Good Clinical Practice – Medical Device 11 Electronic Signatures with Scope and

Electronic Signatures with Scope and Application 2003 - FDA Interpretation of Part 11

and Risk-Based Preventive Controls for Human Food

Frequently Asked Questions for Combination Products

Part 114 - Acidified Foods

The GMP 210/211 regulations address issues including recordkeeping

Good Clinical Practice – Medical Device 11 Electronic Signatures with Scope andGood 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