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UDI Exceptions, Exemptions and Extensions


UDI Exceptions, Exemptions and Extensions

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As the September 24 deadline approaches, a growing number of Class II labelers have been asking whether their devices might be somehow exempt from UDI requirements, or if at the FDA might grant them an extension. Unfortunately, while certain devices are exempt from UDI and the FDA has allowed extensions in rare situations, for most […]

A Risk-Based Approach to UDI Compliance

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As medical device manufacturers scramble to meet Unique Device Identification (UDI) deadlines, a risk-based approach to UDI compliance will help ensure continuity within the quality system, consistency in UDI practice and application, accuracy of the associated data and sustainability of the UDI process. But what is a risk-based approach and how does it apply to […]

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 […]

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 […]