In Force Checked October 24, 2026
Under the QMSR the UDI must also appear in the relevant quality records.
What It Covers
The UDI system: how device identifiers are issued, what goes on labels and packages, and the data submitted to FDA’s Global Unique Device Identification Database (GUDID).
Who It Applies To
Labelers of devices marketed in the US, with exceptions set out in the rule.
Key Requirements
- A UDI on the label and each device package, in plain text and machine-readable form (21 CFR 801.20, 801.40).
- Direct marking for devices intended to be used more than once and reprocessed (21 CFR 801.45).
- Device identifier data submitted to and kept current in GUDID (§830.300 onward).
- Identifiers issued under an FDA-accredited issuing agency’s system, such as GS1, HIBCC, or ICCBBA.
What an Auditor Asks to See
- GUDID records that match the label actually in use.
- The procedure for changing a device identifier when the device changes.
- UDI captured in production and distribution records.
Where Systems Fall Short
- GUDID entries left unchanged after a packaging or labeling change.
- New device identifiers not issued when a change requires one.
How QES Helps
Reconciling the label, the GUDID record, and the change control process so they cannot drift apart.
Related Standards
Sources. eCFR — 21 CFR Part 830 (opens in a new tab); eCFR — 21 CFR Part 801 (opens in a new tab). Status checked October 24, 2026. This page summarizes 21 CFR Part 830; it does not reproduce or replace it. Buy the standard from its publisher, or read the regulation in its official text, before relying on a detail. Not legal advice.