Category Archives: UDI

UDI

Everything You Need To Know About UDI In One Neat Package

UDI Conference 2014 bannerManufacturers of class III medical devices are (hopefully) breathing a sigh of relief today after the recent scurry of activity leading up to yesterday’s deadline for meeting the FDA’s Unique Device Identifier (UDI) regulation.  Now they can relax, right?  Well, odds are, most of them also make class II devices, and maybe even some that are “life supporting and/or life sustaining” devices as well, which means the march toward the next UDI deadlines has to start all over again.

Fortunately, the experience gained by those who faced this first deadline can help guide those who need to meet the next one(s).  Device distributors and hospitals will Continue reading Everything You Need To Know About UDI In One Neat Package →

UDI

FDA Posts Small Entity Compliance Guide For UDI and GUDID

CDRH.CBER.logosYesterday the FDA posted a new document on their website with the title, “Unique Device Identification System: Small Entity Compliance Guide, Guidance for Industry and Food and Drug Administration Staff”.  The document is 23 pages long and it includes an explanation—in what the FDA calls “plain language”—of the FDA’s Unique Device Identification (UDI) system and the Global Unique Device Identification Database (GUDID).  It is aimed at small businesses, but it is a good read for anyone who wants an overview of the regulation.  The guidance contains non-binding recommendations for companies who must meet the UDI final rule, including makers of class III medical devices, which must comply by September 24 of this year.

The document was a requirement under Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996.  That act requires the FDA to Continue reading FDA Posts Small Entity Compliance Guide For UDI and GUDID →

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, Uncategorized

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 →

UDI

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 →

NDC, UDI

UDI And The Approaching End Of The NDC

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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 →

UDI

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 →

UDI

What The UDI Date Format Says About FDA’s Direction

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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 →