Category Archives: UDI

Requesting an Extension/Exception to the U.S. FDA UDI Rules

iStock_000011089235SmallerAre you behind in your preparations for the September 24, 2014 deadline for Unique Device Identification on class III medical devices (see “UDI Deadline For Class III Medical Devices Quickly Approaching”)?  Do you need to apply for an 1-year extension of the compliance date for a class III medical device or a device licensed under the Public Health Service Act?  Do you need to file an exception from or alternative to the requirement for the label of a device to bear a unique device identifier (§ 801.20) or other UDI requirement under 21 CFR 801 Subpart B (Labeling Requirements for Unique Device Identification) for a specified device or a specified type of device?  Do you need to continue using an existing National Health Related Item Code (NHRIC) or National Drug Code (NDC) Labeler Code that was assigned to you by the FDA in the past (see “UDI And The Approaching End Of The NDC”)?

If you answered “yes”, or, “Uh…I think so”, to any of the questions above, then Continue reading Requesting an Extension/Exception to the U.S. FDA UDI Rules

UDI Deadline For Class III Medical Devices Quickly Approaching

UDIexample.small.ucm368901There is a lot of angst in the pharma community right now about the fast approaching DSCSA first deadline for the exchange of transaction data, but the medical device community is dealing with an even earlier deadline:  the September 24, 2014 deadline for UDI on class III medical devices.

The FDA UDI web page lists the following requirements for the September deadline, now less than five months away:

Continue reading UDI Deadline For Class III Medical Devices Quickly Approaching

Bringing UDI and the Global UDI Database to Life

1491-125x125_Static_DatesRxTrace is proud to sponsor the 2014 UDI Implementation Workshop to be held in Baltimore on May 20-22.  The UDI Implementation Workshop is specifically for Class III medical device manufacturers who are in immediate need of information and guidance from the UDI experts at the FDA to meet their September 24, 2014 compliance deadline, and for those Class I and II Device manufacturers that need to jumpstart their UDI adoption efforts.

The FDA UDI Team will conduct a roll-up-your sleeves / deep-dive workshop covering all components of the UDI regulation and the Global UDI Database (GUDID) guidance.  This workshop is strictly focused on critical information exchange, expanded interaction, and heightened networking designed to deliver immediate and actual results in your UDI implementation initiative.  If you need to meet the September deadline, don’t miss this workshop.  It is perfectly timed to give you the boost you need to be ready on time. Continue reading Bringing UDI and the Global UDI Database to Life

UDI And The Approaching End Of The NDC

UDI Barcode Cake
UDI Barcode Cake from last week’s UDI Conference

To be honest, I was somewhat surprised when Jay Crowley announced during last week’s UDI Conference that the U.S. FDA had published the final rules for Unique Device Identification (UDI).  Its publication starts the clock on a host of new requirements designed to identify most medical devices in the U.S. market with the same standard approach.  That is expected to result in the reduction of errors made by medical professionals and also increase the accuracy and efficiency of the supply chain.  I’ve become a little jaded about healthcare Automatic Identification and Data Capture (AIDC) deadlines lately and so the fact that one actually happened caught me slightly off-guard.  Of course, UDI was Continue reading UDI And The Approaching End Of The NDC

InBrief: FDA Publishes Final UDI Rule

UDI.1453-125x125_01The FDA has finally published the long-awaited final rule on Unique Device Identification (UDI).  I was in the audience at the UDI Conference this morning when Jay Crowley of the FDA made the announcement.  Sparkling juice was distributed to the entire audience of 400+ attendees shortly after the announcement.  See “FDA finalizes new system to identify medical devices“).

Yesterday Mr. Crowley arrived at the conference opening with a short beard.  George Wright IV suggested that perhaps he wasn’t shaving until the final rule was published.  Sure enough, he arrived this morning with the beard shaved off.  He was due to Continue reading InBrief: FDA Publishes Final UDI Rule

What The UDI Date Format Says About FDA’s Direction

Jay CrowleyThe 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 are hoping the FDA will be able to announce its publication at their event this Thursday and Friday in Baltimore.  I understand that not everyone is looking forward to its publication, but some are kind of tired of waiting for it.  I’ll bet Jay Crowley and his team Continue reading What The UDI Date Format Says About FDA’s Direction

FDA Proposed UDI: The GUDID Database

The FDA is proposing the creation of a Global Unique Device Identification Database (GUDID), a publicly accessible database that would hold information about each medical device marketed in the U.S.  The GUDID has some similarities with GS1’s Global Data Synchronization Network (GDSN) but rather than accepting the use of GS1’s standard and service, they appear to have decided to roll their own.  Is that a good idea or will it just result in unsynchronized duplication?  Is there a way to use GDSN to serve GUDID (or vice versa)?  Could the GUDID concept work for drugs too? Continue reading FDA Proposed UDI: The GUDID Database

FDA Proposed UDI: AIDC Requirements


Mental Telepathy AIDC.
Photo by Nadya Smolskaya

Linear barcodes2D barcodesRFIDManipulated 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