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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 […]

UDI Labeling: Pitfalls and Best Practices, Part 2 of 2

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UDI labeling can be a challenge for medical device companies as they work towards compliance by the deadline. This post is part two in a two part series to help device manufacturers avoid common mistakes and implement best practices for UDI labeling. You can read part one here. Barcode size The larger a barcode is, the better the […]

UDI Labeling: Pitfalls and Best Practices, Part 1 of 2

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There is no doubt that UDI labeling is a hot topic among medical device manufacturers under pressure to comply with the FDA’s UDI requirements. Europe plans to introduce similar rules that companies will need to adhere to in the next three to four years. With other countries including Brazil, Turkey and China working on their […]

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 […]