Introduction

For manufacturers aiming to distribute medical devices in the United States, compliance with the FDA’s Unique Device Identification rule is mandatory. The process of UDI Submission is a critical part of this compliance, ensuring that devices are properly registered, identified, and traceable throughout their lifecycle.

Preparing for a UDI Submission

Before beginning the UDI Submission process, manufacturers must understand their responsibilities. The “labeler,” typically the manufacturer or brand owner, is responsible for creating and submitting the UDI. Preparation involves:

Assigning a Device Identifier (DI) according to FDA-approved issuing agencies.

Ensuring data accuracy and consistency.

Gathering all production-related information, such as serial numbers and expiration dates.

Having internal systems in place to collect and manage this data is essential for a smooth UDI Submission.

Filing to the GUDID Database

The FDA’s GUDID (Global Unique Device Identification Database) is the repository for all UDI Submission records. Submissions can be made through:

Web Interface: Suitable for low volumes.

HL7 SPL Upload: Ideal for manufacturers with multiple products or frequent updates.

Each UDI Submission must match the device label exactly. Any discrepancies can result in rejections or penalties.

Timely submission is also critical. For instance, higher-risk (Class III) devices typically have earlier deadlines than lower-risk (Class I) products. Keeping track of these timelines ensures ongoing compliance.

Conclusion

Navigating the UDI Submission process is a necessary task for all medical device manufacturers targeting the U.S. market. With careful planning, accurate data management, and a solid understanding of FDA requirements, organizations can ensure a successful UDI Submission and avoid regulatory issues.