GMP Publications - Code of Federal Regulation Handbooks by the FDA

GMP Medical Device Master Reference Guide


 

Over 900 Pages of Guidance and Regulations for the Medical Device Industry Medical Device Manual

Includes:

US FDA Title 21 CFR Parts

21 CFR Part 11 - Electronic Records; Electronic Signatures
21 CFR Part 801 - Labeling - Medical Device
21 CFR Part 803 - Medical Device Reporting
21 CFR Part 806 - Medical Devices; Reports of Corrections and Removal
21 CFR Part 807 - Estab. Reg. and Device Listing for Manuf. and Initial Importers of Devices
21 CFR Part 809 - In-Vitro Diagnostic Products
21 CFR Part 810 - Medical Device Recall Authority
21 CFR Part 812 - Investigational Device Exemptions
21 CFR Part 814 - Premarket Approval of Medical Device
21 CFR Part 820 - Quality Systems Regulations
21 CFR Part 821 - Medical Device Tracking Requirements
21 CFR Part 822 - Postmarket Surveillance
21 CFR Part 830 - Unique Device Identification
 
Guidance

Medical Device QSIT Manual
PMA Premarket Approval and 510 (k) Guidance
Inspection of Medical Device Manufacturers Program 7382.845
Annex 11 Computerized Systems
Annex 15 Qualification and Validation
ICH Q9 - Quality Risk Management
ICH Q10 - Pharmaceutical Quality System
Canadian Medical Device Regulations - SOR/98-282
98/79/EC In Vitro Diagnostic Medical Devices
93/42/EEC Medical Device Directive Updated 2007/47/EC September 2007
            

 

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