GMP Publications - Code of Federal Regulation Handbooks by the FDA

GMP Medical Device Master Reference Guide

GMPMedicalDeviceMasterReferenceGuide
978-1-935131-72-4

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

US FDA Title 21 CFR Parts:

- Part 11 - Electronic Records/Electronic Signatures (ERES)
- Part 801 - Labeling - Medical Device
- Part 803 - Medical Device Reporting
- Part 806 - Reports of Corrections and Removal
- Part 807 - Estab. Reg. and Device Listing for Manuf
- Part 809 - In-Vitro Diagnostic Products
- Part 810 - Medical Device Recall Authority
- Part 812 - Investigational Device Exemptions
- Part 814 - Premarket Approval of Medical Device
- Part 820 - Quality Systems Regulations
- Part 821 - Medical Device Tracking Requirements
- Part 830 - Unique Device Identification

Guidance:

- Added - 820 QSR Checklist with ISO 13485 Reference
- Medical Device QSIT Manual
- PMA Premarket Approval and 510 (k) Guidance
- Inspection of Medical Device Manufacturers 7382.845
- EU 2017/745 Medical Device Regulation

 

 

 

 

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