October 25, 2024
Navigating the FDA's UDI system is critical for manufacturers and labelers of medical devices. The Global Unique Device Identification Database (GUDID) ensures that all medical devices sold in the U.S. are accurately tracked and accessible to both healthcare providers and consumers. If your products fall under the FDA’s UDI requirements, it’s essential to understand the role GUDID plays in compliance and patient safety.
What is GUDID?
GUDID is a database containing key device information submitted by manufacturers and labelers. Each medical device with a UDI must be registered in GUDID to comply with FDA regulations. This allows healthcare professionals, regulators, and patients to easily identify and trace medical devices using the device’s Device Identifier (DI) and Production Identifier (PI).
Why GUDID Compliance Matters
Failing to register your medical devices in GUDID can result in regulatory penalties and delayed product access to the U.S. market. Additionally, having an accurate listing enhances patient safety, enabling providers to quickly access critical details such as the device’s manufacturer, model, expiration date, and any recall information.
What Information is Required for GUDID Registration?
Before creating a GUDID account, you’ll need several key pieces of information about your medical device:
Device Identifier (DI): A unique code identifying the device model.
Production Identifier (PI): Batch numbers, expiration dates, and other production data.
Brand Name & Model: The name and model of the device.
FDA Premarket Submission Number: If applicable, this is the approval number or clearance for devices subject to premarket approval or notification.
FDA Classification Information: The medical device classification, including its intended use and risk category.
Device Labeler Information: Manufacturer or labeler name and contact information.
Commercial Distribution Status: Information about whether the device is currently available for sale in the U.S.
Packaging Configurations: Details about how the device is packaged, including multiple levels of packaging if relevant.
Steps to Create a GUDID Account
Get an FDA GUDID Account: You’ll need to create an account through FDA’s Electronic Submission Gateway (ESG). This account will serve as your entry point for submitting and managing device information.
Obtain a GUDID Labeler Account: If you are the labeler of the device, request access to the GUDID system through the FDA’s Unified Registration and Listing System (FURLS). Only authorized labelers can submit device data. .
Submit Device Information: Once your account is set up, you’ll submit device data, including all required information, through the GUDID system. Be sure to double-check the accuracy of each entry, as mistakes can result in compliance issues or delays.
Provision Consulting Group: Your Partner for GUDID Compliance
At Provision Consulting Group, we make GUDID compliance easy. Whether you’re submitting your first device or need ongoing support, our team of experts helps businesses meet FDA requirements, ensuring that every detail is submitted correctly and on time. We guide you through the entire process, from setting up your GUDID account to ensuring that all device information is properly registered and updated.
Conclusion: Protect Your Business and Patients with Accurate GUDID Listings
Compliance with the FDA’s GUDID requirements is essential for any business that manufactures or labels medical devices. Proper registration not only helps avoid costly fines but also ensures that your devices can be safely and legally distributed in the U.S. market. With Provision Consulting Group, you can rest assured that your GUDID submissions are in good hands.
Ready to simplify your GUDID compliance? Contact us today to learn how we can help ensure your devices are listed accurately and meet FDA requirements.
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