Tag Archives: medical device supply chain

FDA Guidance, UDI

FDA Considering A Delay Of A Small Part Of The UDI Rule

1622-468x60_AprilFor the second time this week, the FDA posted something related to the things I pay the most attention to.  Earlier this week it was about the DSCSA.  This time it was a draft guidance for comment on a proposed delay in enforcement of a small part of the Unique Device Identification (UDI) final rule.  I’ve seen a lot of mentions around the internet about this new FDA posting but none of them really explain it very well (including the FDA).  I’d like to take a stab.

Way back in around 1970 the FDA created a numbering system for drugs and one for devices.  The one for drugs Continue reading FDA Considering A Delay Of A Small Part Of The UDI Rule →

Healthcare Legislation

RAPS Explains The 21st Century Cures Act

House Engergy and Commerce CommitteeAlexander Gaffney, RAC, Manager, Regulatory Intelligence at the Regulatory Affairs Professionals Society (RAPS) is right on top of any new proposed legislation related to FDA and other health-related federal government agencies.  Last week he reported on the contents of a discussion draft of the “21st Century Cures” Act that was made public by the House of Representatives Energy and Commerce Committee (see Gaffney’s “Regulatory Explainer: The 21st Century Cures Act”).

At 393 pages, the draft bill, if enacted in its current form, would Continue reading RAPS Explains The 21st Century Cures Act →

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 →