FDA Extends UDI Compliance Deadline for Some Class II Medical Devices

The FDA says it is extending the compliance deadline for some Class II medical devices from September 24th, 2016 to September 24th, 2018. The extension will give manufacturers two more years to meet the requirements of the UDI Final Rule.

Collections of two or more different devices packaged together in which the devices in the package are not individually labeled, often referred to as a convenience kit are included in the extension. The FDA is also extending the deadline for repackaged single-use devices that are not required to have a UDI on the device itself, but rather on the package provided the device stays in the package until use. The extension does not include collections of devices that are implantable, life-sustaining or life-supporting.

Learn more about the extension from Jay Crowley by watching our webinar, Answers to Your UDI Questions.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.


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