Global UDI Database (GUDID) Registration Systems

The Global Unique Device Identification Database (GUDID) is the FDA’s database where all medical devices commercially distributed in the United States must be registered.  The FDA’s Unique Device Identification (UDI) Final Rule requires the labeler of each medical device to ensure the device is registered in the GUDID.

Depending on the risk class and other regulations, there are specific deadlines by which each device must be registered.

There are several methods to submit data to the GUDID.  Submission methods include manual data entry, enterprise applications interfaced to the GUDID and GDSN registration processes and third-party service providers.  USDM Life Sciences can help you develop and implement the method that best fits your company’s specific needs.

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  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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