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GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 820 - Quality System Regulations

1-933734-50-7

US FDA Title 21 CFR Part 820 Pocket Guide

The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.

The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act).

This part establishes basic requirements applicable to manufacturers of finished medical devices.

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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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