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Class II UDI Submissions: What you need to know, Pt. 1/2



The FDA’s final rule on Unique Device Identification (UDI), published Sept. 24, 2013, includes a requirement to submit UDI records electronically to the FDA’s Global Unique Device Identification Database (GUDID). The mandate features a phased implementation scheme from Class III (highest risk) to Class I (lowest risk) devices. As we approach the end of 2015, Class II device labelers are next to face a compliance date.

If your organization labels Class II devices, here are some of the initial steps you’ll need to take to get ready:

1. Know the UDI compliance deadlines for Class II devices

Labelers of Class III medical devices were required to submit UDI data records to the FDA by Sept. 24, 2014. The 2015 compliance date for Implantable, Life-Supporting and Life-Sustaining device labelers was extended by one month to October 24, 2015.

Class II labelers face a compliance date of three years after the release of the final rule, or September 24, 2016, to submit their UDI records to the GUDID.

UDI Article Download

2. Create a compliance plan

Review the FDA UDI requirements for your specific products and determine what resources in your organization will be required to gather, validate, and submit the data.

Remember, this data will likely be scattered throughout your organization and locating and collecting it will require cooperation from various departments and support from the C-suite to implement a comprehensive plan.

3. Set up a GUDID account

Setting up a GUDID account involves requesting access from the FDA, and authorizing individuals in your company to put information into the GUDID database. To set up an account, you will need to give the FDA your company’s Data Universal Number System (DUNS) number.

FDA Resource: A presentation explaining the account setup process is available here under the Unique Device Identification (UDI) System tab, along with other valuable training materials.

Keep an eye out for Part 2 of this blog next week, when we will discuss other important steps for Class II labelers to take when preparing to meet the FDA’s UDI submission mandate.

In the meantime, contact the experts at Reed Tech to learn more about how your company can meet the UDI requirements.

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