Regulatory library

21 CFR Part 601

Part 601 covers licensing of biological products. Its rules on reporting changes decide when a change to equipment or a facility needs FDA approval first.

ValDoc's library holds 1 provision of 21 CFR Part 601. 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 601.12(a)-(f)

    Unchanged since

    Changes to an approved application

    Open eCFR

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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.