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GMP Publications - Code of Federal Regulation Handbooks by the FDA

Updated 2024 - 21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination

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Good Clinical Practices (GCP) Regulations for Medical Devices - Last Updated 2024

US FDA Title 21 CFR Parts

Part 11 - Electronic Records; Electronic Signatures
Part 50 - Protection of Human Subjects
Part 54 - Financial Disclosure by Clinical Investigators
Part 56 - Institutional Review Boards
Part 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
Part 812 - Investigational Device Exemptions
Part 814 - Premarket Approval of Medical Devices
Part 820 - Quality Systems Regulations
The 510k & Premarket Approval (PMA) Guidance Document
















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Upgrade your order or view other GMP Products that you may be interested in:

GMPMedicalDeviceMasterReferenceGuide
GMP Medical Device Master Reference Guide

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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