21 CFR Part 830 – Unique Device Identification (UDI) System

This topic is part of the SG Systems Global regulatory glossary series.

Updated October 2025 • FDA / CDRH • Device Labeling & Traceability

21 CFR Part 830 establishes the FDA’s Unique Device Identification (UDI) System — a standardized method for identifying medical devices through a unique alphanumeric code on labels and packages, linked to the Global Unique Device Identification Database (GUDID). It is a cornerstone of device traceability and postmarket surveillance.

“UDI transforms every device into a digital record — traceable from factory to patient through a single global identifier.”

1) What It Is

Part 830 requires manufacturers to assign a unique identifier to each device version or model and to submit device data to the FDA’s GUDID. The identifier must appear in both human-readable and AIDC (barcode or 2D) formats on the label, device package, and sometimes on the device itself.

Scope & Application. Applies to all medical device manufacturers, labelers, and importers marketing products in the U.S. Certain Class I devices and custom devices may be exempt under specific conditions.

Core requirements of Part 830:

• 830.10 UDI Format & Issuing Agencies. UDI must be issued under FDA-accredited standards (GS1, HIBCC, or ICCBBA).
• 830.20 UDI Elements. Composed of a Device Identifier (DI – static) and a Production Identifier (PI – dynamic: lot, serial, expiration date, UDI carrier).
• 830.300 & 301 Labeling. UDI must be on the device label, package, and certain direct marking applications for reusable devices.
• 830.320 Data submission to GUDID. Manufacturers must submit device master data electronically to the FDA database.
• 830.360 Recordkeeping. UDI must be retained in production and distribution records to support tracking under Part 821.

Relation to other rules. UDI data under Part 830 links to event and recall systems in Part 803 (MDR), Part 806 (Corrections & Removals), and Part 821 (Tracking).

2) Compliance Structure & Labeling Practice

FDA requires the UDI to be verified against the GUDID database and kept consistent across packaging levels and system integrations. UDI integration is also expected in electronic health records (EHRs) and hospital inventory systems.

• Label hierarchy. Each package level must display the UDI that identifies the contained device configuration.
• Barcode requirements. AIDC format must be scannable and durable through intended use and storage conditions.
• Data management. Changes to DI or PI trigger a new record submission to the GUDID.
• Reprocessing & Re-use. Reusable devices requiring reprocessing must have direct UDI marking on the device itself.

UDI and digital traceability benefits:

• Improved recall speed and accuracy.
• Enhanced inventory and lifecycle management.
• Reduced counterfeit and mix-up risk.
• Better data for postmarket safety analysis and public reporting.

3) FAQ

Q1. What is UDI?
A Unique Device Identifier that uniquely identifies a specific device version or model and production data, appearing on its label and stored in the FDA’s GUDID.

Q2. What is the difference between DI and PI?
The Device Identifier (DI) is the fixed portion that identifies the labeler and device model. The Production Identifier (PI) is dynamic, identifying lot, serial, and expiration data.

Q3. Who issues UDI codes?
FDA-accredited agencies such as GS1, HIBCC, or ICCBBA issue and govern UDI standards.

Q4. What is GUDID?
The Global Unique Device Identification Database is the FDA-hosted repository of device information linked to each UDI for public and regulatory use.

Q5. Where can I read the rule?
Full text available at 21 CFR Part 830 (eCFR).

4) How It Relates to V5

V5 by SG Systems Global supports UDI compliance and traceability through its integrated eDHR, QMS, and WMS modules. Each device record and label is automatically linked to UDI data for Part 821 tracking and Part 806 recall actions.

• UDI label generation. Prints barcodes and human-readable labels with GS1/HIBCC formats directly from controlled masters.
• Master data control. Device master records store UDI DI/PI pairs for each configuration.
• Electronic traceability. UDI links eDHR to distribution and recall records for instant searchability.
• API integration. V5 Connect API enables exchange with ERP and labeling systems to maintain UDI synchronization.
• Audit support. UDI records can be queried live by inspectors to trace any device through its manufacturing and distribution chain.

End-to-end example. A Class III implant is produced and serialized with UDI at packaging. V5 links the UDI to its lot in eDHR and shipment record in WMS. If a Part 806 correction occurs, V5 instantly identifies affected UDI entries, initiates customer notification, and updates CAPA records under Part 820 oversight.

Primary References:
• FDA eCFR: 21 CFR Part 830
• FDA UDI Portal: FDA UDI System Overview
• Related Rules: Part 806 | Part 821 | Part 820