What is UDI and who needs it?

UDI (Unique Device Identification) is an FDA system requiring most medical devices sold in the U.S. to bear a unique identifier. It applies to manufacturers and labelers of devices distributed in the U.S., with compliance timelines staggered by device class.

GUDID (Global Unique Device Identification Database) is FDA's publicly searchable database of device identification information. Device labelers must submit required data elements to GUDID for each device they market in the U.S.

What happens if my UDI data is incorrect?

Incorrect or missing UDI data can trigger FDA enforcement actions, complicate post-market surveillance, and create issues with recall management. Keeping GUDID data accurate and current is an ongoing compliance obligation.

How much does UDI/GUDID support cost?

Assurentry charges $349 per device family for UDI data preparation, GUDID submission support, and ongoing change management. Volume pricing is available for companies with large device portfolios.

What are the UDI compliance deadlines by device class?

FDA implemented UDI requirements on a staggered timeline: Class III devices since September 2014, implantable/life-supporting Class II devices since September 2015, remaining Class II devices since September 2016, and Class I devices since September 2018. Direct marking with a permanent UDI on reusable devices requiring reprocessing was required by September 2020 for Class III and September 2022 for Class I/II. Assurentry verifies your devices meet all applicable deadlines.

Do foreign device manufacturers need to comply with UDI requirements?

Yes. Any device labeler whose products are distributed in the U.S. must comply with FDA's UDI rule (21 CFR Part 830), regardless of where the device is manufactured. Foreign manufacturers must submit device identification data to GUDID using the same requirements as domestic labelers. Assurentry supports international device teams with data preparation, GUDID submissions, and coordination with their U.S. Agent for registration alignment.

Can I manage UDI/GUDID compliance on my own without professional support?

You can submit GUDID data directly through FDA's GUDID system, but the process involves specific HL7 SPL formatting, mandatory and conditional data attributes (over 70 fields per device), and ongoing update obligations when packaging or device configurations change. Errors in GUDID submissions can result in rejected records and compliance gaps. Assurentry handles the technical data preparation and validates submissions before they reach FDA.

What is the difference between a Device Identifier (DI) and a Production Identifier (PI)?

The UDI consists of two components: the Device Identifier (DI), a mandatory fixed portion identifying the device labeler and model, and the Production Identifier (PI), which includes variable information such as lot number, serial number, manufacturing date, and expiration date. The DI is submitted to GUDID, while PI elements appear on the device label or package. Assurentry ensures both components are correctly configured for each device in your portfolio.

UDI/GUDID • Official FDA Process

UDI & GUDID
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UDI data preparation, GUDID submission support, and change management for medical device identification compliance.

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The Compliance Roadmap

A transparent, step-by-step workflow from start to certification.

Data Assessment

We review your device portfolio and identify UDI requirements based on device class and applicable timelines.

Data Preparation

We help prepare and validate your UDI data elements: device identifiers, production identifiers, and required GUDID attributes.

Submission Support

We support your GUDID submission process and verify that all required data elements are complete and accurate.

Ongoing Maintenance

We help manage UDI data updates when device configurations, packaging, or labeling change over time.

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No hourly billing. No hidden retainer fees. Just simple, predictable compliance.

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UDI & GUDID Support

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What's Included

UDI data preparation and validation
GUDID submission readiness review
Device identifier assignment guidance
Production identifier configuration
Change management for device updates
Compliance status monitoring

Frequently Asked Questions

Common questions about this regulatory requirement.

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