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GMP Publications - Code of Federal Regulation Handbooks by the FDA

Medical Devices

GMP Medical Device Master Reference Guide
21 CFR 820 - Quality System Regulations
Medical Device Quality Systems Manual with 11, 210/211, 820 and QSR Audit Checklist
In Vitro Diagnostics Master Handbook
Drug & Device GMP Desk Reference Set
21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook
21 CFR 11, 210/211, 606, 820 - Electronic Records with Drug, Blood and Device QSR Industry GMPs
21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs
Updated 2024 - 21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination
21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs
21 CFR 11, 58, 820 - Electronic Records with GLP and QSR
21 CFR 11, 820 - Electronic Records with Quality Systems Regulations
21 CFR 58, 820 - GLP and QSR
21 CFR 801 - Labeling - Medical Device
21 CFR 803 - Medical Device Reporting
21 CFR 806 - Medical Devices; Reports of Corrections and Removal
21 CFR 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
21 CFR 809 - In-Vitro Diagnostic Products
21 CFR 810 - Medical Device Recall Authority
Updated 2024 - 21 CFR 812 - Investigational Device Exemptions
21 CFR 814 - Premarket Approval of Medical Device
21 CFR 820 - Quality System Regulations-SPANISH
Electronic Systems Master Handbook 1
US and EU GMPs with ICH Q7, Q8(R2), Q9(R1), Q10
Medical Device QSIT Manual with 11 and 820
Medical Device QSIT Manual with 11, 803, 806, 820 and 821
Medical Device Quality Systems Manual with 820 and QSR Audit Checklist
US, EU and Canadian Medical Device Combination
US, EU and Japanese GMPs
Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT
EU Medical Device Regulation 2017-745
Canadian - SOR98-282 Medical Devices Regulations
In Vitro Diagnostics 2017/746 Medical Devices
21 CFR 11, 820 QSR and 830 UDI
21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master
21 CFR 4 - Regulation of Combination Products
503B Compounding Master Guide
GMP International Master Reference Guide
Title 21 CFR Parts 1 - End Nine Volume Set
21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024
US FDA, Canadian and European MDR
21 CFR Part 4 Regulations for Combination Devices with 21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024
GMP Manufacturing Handbook
GMP Boot Camp Training Certificate and GMP Handbook
example: 211, ISBN, Drug, GMP, Etc. - Press Enter
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