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Labeling or Data Submission, Which UDI Step Comes First?


Labeling or Data Submission, Which UDI Step Comes First?

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When I speak to medical device industry members about the FDA’s requirements for submitting their UDI data to the GUDID, I am frequently told they are not worried about that aspect yet. I often hear, “We are just focusing on getting our labeling completed at this point then we will submit to the GUDID at […]

FDA UDI Enforcement: 4 Things to Consider

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While recently speaking with a regulatory manager who works at a medical device manufacturer with a large Class II product portfolio, I was surprised to hear that his organization was not concerned about meeting the FDA’s UDI requirements by the September 24 deadline. He confided he is personally worried about the potential consequences, but upper […]

UDI Submission Load Testing

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As I talk to medical device industry members about their plans for UDI, I continue to find many organizations that have not yet begun making their submissions to the GUDID. A lot of labelers have collected their data, modified their labels and taken the other steps necessary to meet the FDA’s UDI mandate but are […]

HL7 Structured Product Labeling and the True Cost of the Free FDA Web Interface

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Many in the medical device industry make plans to use the free FDA Web Interface based on the assumption that they don’t have enough products to warrant the use of Structured Product Labeling (SPL) for their GUDID submissions. The decision would seem to make sense for a company with 100 or fewer UDI device records […]

UDI: How do I assign Device Identifiers?

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As you work on implementing UDI, you may be wondering how to assign the Device Identifier (DI) portion of the UDI to your products and how to make sense of the different levels of DIs in a single GUDID record. These are questions we receive from industry members all the time. After determining your issuing […]

UDI Crunch Time: Preparing Your Data for Submission

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Medical device labelers face a number of challenges as they work to comply with the UDI Rule, including electronic submission of UDI data records to the FDA’s Global Unique Device Identification Database (GUDID). Join Reed Tech UDI expert John Lorenc on March 22 to learn how best to prepare your UDI data for submission to […]