Search Results for: HIBCC

UDI

What The UDI Date Format Says About FDA’s Direction

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The U.S. FDA is poised to publish their final Unique Device Identification (UDI) rule any day now.  The publication was due earlier in the summer but has apparently been held up in the review by the Office of Management and Budget (OMB) without any kind of accurate timeline.  The organizers of this year’s UDI Conference … Continue reading What The UDI Date Format Says About FDA’s Direction →

Location Identification

FDA Chooses DUNS For Unique Facility Identifier

Last week the FDA published draft, non-binding guidance for their recommended unique facility identifier (UFI) for use in registering foreign and domestic drug  establishments.  Last year, Congress passed the FDA Safety and Innovation Act (FDASIA) to address safety concerns induced by inspection gaps of facilities outside the United States and other issues (see “The Supply … Continue reading FDA Chooses DUNS For Unique Facility Identifier →

supply chain security

The Supply Chain Provisions Of The FDA Safety & Innovation Act

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Last fall the U.S. Congress passed the Food and Drug Administration Safety and Innovation Act, or FDASIA, and the bill was signed into law by President Obama.  The purpose of the legislation was primarily to re-authorize user fees that are paid by manufacturers of drugs, medical devices and biologics, but the law also contains quite … Continue reading The Supply Chain Provisions Of The FDA Safety & Innovation Act →

GS1

Should GS1 Continue Developing ePedigree Standards?

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For the first time since GS1 produced the Drug Pedigree Messaging Standard (DPMS) standard in 2005, GS1 has just published a call-to-action for the formation of a new standards development group to focus on a new pedigree-related standard.  The new group will be called the “Pedigree Security, Choreography and Checking Service (PSCCS) Mission Specific Work … Continue reading Should GS1 Continue Developing ePedigree Standards? →

UDI

FDA Proposed UDI: AIDC Requirements

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  Linear barcodes?  2D barcodes?  RFID?  Manipulated DNA stands?  Microscopic pattern recognition?  Mental telepathy?  Which Automatic Identification / Data Capture (AIDC) technology(ies) can you expect on the medical devices you buy in the U.S. supply chain in the future?  This is the second in a multi-part series of essays examining various aspects of the recently … Continue reading FDA Proposed UDI: AIDC Requirements →

UDI

FDA Proposed UDI: A Revolution In Number Assignment

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Like so many others, I had been patiently awaiting the publication of the U.S. Food and Drug Administration’s (FDA’s) Unique Device Identification (UDI) proposed rules.  Now that they are out I’ve been studying them and I think I will have enough to say about them that I will cover the topic in a multi-part series.  … Continue reading FDA Proposed UDI: A Revolution In Number Assignment →

SNI

Anatomy Of An FDA SNI

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The U.S. Food and Drug Administration (FDA) published their “Standardized Numerical Identification (SNI) for Prescription Drug Packages – Final Guidance” document almost two years ago (see my essay “FDA Aligns with GS1 SGTIN For SNDC” from back then).  The guidance was published as purely non-binding recommendations that reflected the Agency’s current thinking, but in my … Continue reading Anatomy Of An FDA SNI →