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Class II UDI compliance: The data you will need to submit


There are 62 different data elements in the GUDID data record for a single product. As a Class II medical device labeler, you are responsible for locating, collecting and submitting 55 of those elements (the FDA will populate the other seven data fields).

This means that companies preparing to meet the FDA’s Sept. 24, 2016, deadline for Class II Unique Device Identification (UDI) submissions need to locate a tremendous amount of data, especially if they have large product portfolios.

The required data fall into six categories:

1. Identification
Identification information for a product ranges from the obvious (brand name and device description) to the potentially complex, such as the name of a secondary device identifier issuing agency.

2. Labeler
As the labeler, you will provide your company’s D-U-N-S (Dun & Bradstreet) Number. This will enable the FDA to automatically populate the labeler name and address fields for the record.

You will also need to provide a phone number and email address for the person at your company who should be contacted with questions about the device.

3. Regulatory
Extensive information is required about the product’s regulatory status and history, including premarket exempt status and premarket submission number.

4. Packaging
Ready for more numbers? You will be asked to supply the device count, a unit of use device identifier number, a packaging identifier number, and more.

5. Production Control
You’ll be asked to indicate (by a “yes” or “no” response) if the product has a lot/batch number, serial numbers, manufacturing date, expiration date, and donation ID.

6. Characteristics
Eighteen product characteristics must be reported. They range from storage and handling conditions to the presence or absence of rubber.

Our new ebook, Class II UDI Submissions Guide: Keys to Meeting the 2016 GUDID Compliance Date includes a complete list of these elements, plus advice on how to find and collect Class II device data from diverse parts of your organization.


Finding Your Data

It is essential to locate your data early in the preparation process so you know what is readily available and what data will take more work to compile. In some cases, companies find that the required data for a particular element does not currently exist in their organization’s various record-keeping systems. If this is the case for your company, you will need time to put a system or procedures in place to capture and track those data elements for each product.

In other cases, you may find multiple conflicting data for a particular field. You will need to leave time to investigate and resolve these issues.

Maintaining an Ongoing System

Having in place systems and procedures to track these data will be essential for organizations that label Class II devices. Remember, compliance is not a one-time event. Labelers will be required to update product information whenever the data in an element (such as unit size or packaging type) changes or the FDA requirements are updated. The method you choose to manage GUDID submission data this year will be needed repeatedly in the future.

As always, if you have any questions regarding this material, our Class II ebook or how to get started on the path to UDI/GUDID compliance, please contact us, we will be happy to help.

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