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Tag Archives: UDI

07 Sep

The deadline for the UDI compliance is fast approaching and at this juncture the FDA rule to extend the deadlines for certain class II device is a big relief for some labelers!!!

September 7, 2016 - 7:57 pm
FDA Updates

FDA has extended the compliance date for UDI label and GUDID submission requirements to September 24, 2018, for certain class II devices!! FDA has also clarified that the UDI and GUDID compliance date for certain device constituents of certain combination products will be September 2018. The UDI and GUDID extension applies to the below devices

09 Oct

Incorporation of (UDIs) in Healthcare settings

October 9, 2015 - 2:41 am
FDA Updates

On the same date, the Centers for Medicare and Medicaid Services (CMS) published a final rule that specifies the requirements that eligible providers and hospitals must meet to qualify for Electronic Health Record (EHR) incentive payments and solicits feedback about the Electronic Health Record (EHR) Incentive Programs going forward. Goal of this Activity: Incorporation of

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