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


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 Ask the Experts Webinar Video Now Available

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To hear Gary and John’s answers to these questions, you can visit our website and access the recording of the entire webinar. You can also download the presentation slides.

Here Comes 2016 (and the Class II UDI Deadline)

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We hope you have some great plans for New Year’s Eve. Eat some cake, drink a glass of champagne and kiss that special someone at midnight. Then rest up over the long weekend because 2016 is going to mean a lot of work for the Class II device companies. Here are some things to keep […]

Class II UDI Compliance Efforts: Smooth Sailing or Stormy Seas?

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Earlier this month, Reed Tech UDI expert Gary Saner presented a webinar about how Class II device labelers can ensure smooth sailing through the process of submitting UDI records to the FDA’s GUDID database. (You can access the slides and presentation recording here.)  The submission process is a voyage through five stages, each with its own […]

UDI Data Submission Hurdle: High Submission Volumes

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The UDI compliance deadline of October 24, 2015 for labelers of Implantable, Life Supporting and Life Sustaining (I/LS/LS) devices recently passed. While the FDA and industry expected the increase in the number of I/LS/LS records submitted in 2015 from those Class III records submitted in 2014 to cause significant challenges for the medical device industry, […]