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FDA Update on UDI Implementation


On December 18, 2014, the U.S. Food & Drug Administration (FDA) released an Update on UDI Implementation for Registered Medical Device Establishments.

The FDA reiterated UDI requirement compliance dates for Class II devices and non-Class III implantable, life-sustaining and life-supporting devices, and stressed that device labelers are strongly encouraged to take the necessary steps toward compliance well before their mandated compliance deadlines.

A number of updates to the UDI mandate were made in 2014, including a one-year extension for contact lenses and Inter Ocular Lenses as well as a one-year extension on UDI labeling compliance for numerous implantable devices. FDA also noted in the update that it expects a number of additional policy issues will be addressed in the upcoming year, including UDI direct marking requirements, convenience kits, posting of decisions on UDI exceptions and alternatives, and issuance of additional Frequently Asked Questions (FAQs).

FDA additionally reaffirmed its commitment on implementing UDI throughout the upcoming years, and pledged to offer the medical device industry, health care systems, clinicians and patients the tools necessary for a successful adaptation of UDI standards.

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