Regulatory library

21 CFR Part 820

Part 820 is FDA's quality management system regulation for medical devices. Since 2 February 2026 it incorporates ISO 13485:2016 by reference, and its old production and process validation sections were removed.

ValDoc's library holds 3 provisions of 21 CFR Part 820. This page is guidance in our words. The regulation's own text governs.

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Thirty minutes. Bring one piece of equipment.

Provisions in ValDoc's library

  1. 21 CFR 820.1(a); 820.7(b); 820.10(a)

    Effective

    Scope; Incorporation by reference; Requirements for a quality management system

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  2. 21 CFR 820.70Superseded

    Unchanged since

    Production and process controls

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  3. 21 CFR 820.75Superseded

    Unchanged since

    Process validation

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Other regulations

Every regulation in ValDoc's library

See your own equipment in ValDoc.

Bring one piece of equipment, or one you plan to buy, and we’ll walk it through ValDoc with you, from its intended use to the signed record.

Thirty minutes. Bring one piece of equipment.