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UDI

FDA Proposed UDI: AIDC Requirements

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Mental Telepathy AIDC.
Photo by Nadya Smolskaya

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 proposed Unique Device Identification (UDI) rule by the U.S. Food and Drug Administration (FDA) (see last week’s essay, “FDA Proposed UDI: A Revolution In Number Assignment”.

The proposed FDA UDI rule requires the use of human readable and at least one AIDC technology to carry the new standardized identifier on all non-exempt devices and/or their packages.  An AIDC technology is a way of 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.  Today I want to look at just one of the differences between the FDA’s proposed UDI rule for medical devices and their National Drug Code (NDC), the pharmaceutical unique identifier.  The NDC structure was first conceived by the FDA back in 1969.  For more about the history of the NDC see my essay “Anatomy Of The National Drug Code”.

The thing I find fascinating is that at the same time they created the NDC for drugs back in 1969 they also created a comparable identifier for medical devices.  They called it the National Health Related Item Code (NHRIC).  Both the NDC and the NHRIC were voluntary until 1972 when the FDA made Continue reading FDA Proposed UDI: A Revolution In Number Assignment →

FDA

FDA Aligns with GS1 SGTIN For SNDC

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Last Friday, the FDA published the long awaited guidance on their Standardized Numeric Identifier (SNI) for prescription drug packages.  This was right on time since the FDA Amendments Act  of 2007 gave the agency 30 months to develop a standard for SNI and they published, almost to the day, 30 months later.  Well done.

The published guidance is not radically different from the draft guidance that the agency published under the same name in January of 2009.  In fact, in my view, the only really important difference is how the Continue reading FDA Aligns with GS1 SGTIN For SNDC →