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What you need to know about the UDI compliance date extension

Susan Gosnell Life Sciences Leave a Comment

On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued an extension letter to device labelers, extending the UDI compliance date to September 24, 2018 for certain Class II devices. The devices impacted by the extension are classified as: Convenience kits Repackaged single-use devices The letter also clarified that the compliance date for biologic and drug device constituents …

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Helpful resource in planning for September UDI deadline for Class II device compliance

Susan Gosnell Life Sciences Leave a Comment

Manufacturers of Class II medical devices must comply with the FDA’s Unique Device Identifier (UDI) regulations by September 2016, the latest in a series of deadlines for varying devices. Are you ready? The FDA manages a Global Unique Device Identifier Database (GUDID), to which manufacturers must submit their device details, via one of three accredited agencies. There is a fair …

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UDI labeling: common mistakes and best practices

Marko Vrbnjak Life Sciences Leave a Comment

There’s no doubt that UDI is a hot topic among medical device manufacturers. They are currently 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. Other countries like Brazil, Turkey and China are introducing their own rules. It’s clear that …