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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!!!

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

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

25 Jun

Unique Device Identification: Direct Marking of Devices – Draft Guidance

FDA released this draft guidance to provide its current thinking on direct marking of devices in regards to UDI requirements. For devices that are intended to be used more than once and reprocessed before each use, they must bear a UDI on the device itself if it is also are required to have a UDI

11 Apr

NDC/NHRIC Labeler codes for Medical Devices – FDA’s stand

We have been recently getting a lot of queries whether or not FDA can still issue NDC/NHRIC labeler codes for medical devices with the recent advent of the new UDI (Unique Device Identification) regulations being implemented by the FDA. The answer to this question is NO!!! Some of the clients are arguing about the NDC

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