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GMP Publications - Code of Federal Regulation Handbooks by the FDA

US, EU and Canadian Medical Device Combination

978-1-935131-28-1

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 Invest.
Part 56 - Institutional Review Boards
Part 801 - Labeling Medical Devices
Part 803 - Medical Device Reporting
Part 806 - Medical Devices; Reports of Corrections & Removals
Part 807 - Establishemnt Registration and Device Listing for Manufacturers & Initial Importers of Devices
Part 812 - Investigational Device Excemptions
Part 814 - Premarket Approval of Medical Devices
Part 820 - Quality Systems Regulations
PMA & 510k Guidance Document,

Canadian Medical Device Regulations - Last Amended on February 22, 2023

EU 2017/745 Medical Device Regulation

US FDA Inspection of Medical Device Manufacturers 7382.845

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