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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 […]

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 […]