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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 […]

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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Where am I - content-blog-article.php

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 […]