[Home](/)/[Resources](/resources)/US Unique Device Identification

USUDI

# US Unique Device Identification

FDA's UDI system requires unique identification of medical devices to improve tracking and patient safety. Understanding UDI components, labeling requirements, and GUDID submission is essential.

Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fus-unique-device-identification)

At a glance

Key requirements

4

UDI components

4

FAQs

5

## Key requirements

### UDI on Device Label

Each device label must include a UDI in human-readable and automatic identification and data capture (AIDC) formats.

**Applies to:** All medical device labels and packaging

### UDI on Device

For devices intended for multiple use, the UDI must be directly on the device if practicable.

**Applies to:** Devices intended for multiple use

### GUDID Submission

Device information must be submitted to FDA's Global Unique Device Identification Database (GUDID).

**Applies to:** All devices requiring UDI

### Expiration Date

If the device has an expiration date, it must be included as part of the UDI.

**Applies to:** Devices with expiration dates

## UDI components

Device Identifier (DI)

A unique numeric or alphanumeric code specific to a device model. Identifies the manufacturer and device version.

Production Identifier (PI)

Identifies the current production run or batch, expiration date, and manufacturing date. Required for most devices.

Issuing Agency

The organization that issues the UDI. Common issuers include GS1, HIBCC, and ICCBBA.

Format

UDI must be provided in both human-readable form and AIDC (barcode or RFID) format.

## Implementation timeline

### Class III

**Deadline:** September 24, 2014

**Status:** Required

### Class II

**Deadline:** September 24, 2016

**Status:** Required

### Class I

**Deadline:** September 24, 2018

**Status:** Required

### Exempt Devices

**Deadline:** September 24, 2020

**Status:** Required for exempt devices

## Common compliance mistakes

Not including both formats - UDI must be in human-readable and AIDC formats

Incorrect DI assignment - DI must be properly assigned by an issuing agency

Missing GUDID submission - device information must be submitted to GUDID

Not updating GUDID - changes to device information must be updated in GUDID

Missing PI for applicable devices - PI is required for most devices

Using wrong issuing agency - must use FDA-accepted issuing agency

## Frequently asked questions

### What is UDI and why is it required?

UDI (Unique Device Identification) is a system for uniquely identifying medical devices. It improves device tracking, reduces medical errors, and facilitates recalls. UDI is required by FDA for most medical devices to improve patient safety.

### What is the difference between DI and PI?

DI (Device Identifier) identifies the device model and manufacturer. It's static for a given device model. PI (Production Identifier) identifies the specific production run, batch, expiration date, and manufacturing date. PI varies by production batch.

### Which issuing agency should I use?

FDA accepts several issuing agencies including GS1, HIBCC, and ICCBBA. GS1 is the most commonly used. Choose an issuing agency that meets your needs and is accepted by FDA. You must register with the issuing agency to obtain UDIs.

### What information must be submitted to GUDID?

GUDID requires device information including DI, PI, device name, classification, manufacturer information, and other details. The specific data elements are specified by FDA. Submission is required before devices can be distributed.

### Are there exemptions from UDI requirements?

Yes, some devices are exempt including custom devices, research use only devices, and certain low-risk devices. Check FDA's exemption list to determine if your device is exempt. Exempt devices may still have alternative requirements.

**Disclaimer:** This guide provides general information about UDI requirements. Device-specific determinations require analysis of FDA regulations. Always verify current requirements with FDA resources or qualified compliance professionals.

🇺🇸 US roadmap for your product

Every standard, document, and test that applies — free, no account required.

See your free roadmap[

Want an expert to take your product through 🇺🇸 US compliance for you?

One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts.

See compliance services](/services)

Related guides

*   [FDA Medical Device RegulationComplete guide to FDA medical device regulation.](/guides/fda-medical-device-regulation)
*   [US FDA Registration and ListingComplete guide to US FDA registration and listing.](/guides/us-fda-registration-and-listing)
*   [US Quality System RegulationComplete guide to US Quality System Regulation.](/guides/us-quality-system-regulation)
*   [US Medical Device ReportingComplete guide to US medical device reporting.](/guides/us-medical-device-reporting)