Tag Archives: GS1 US

Thank You Bob Celeste!

March 16, 2015 Dirk Rodgers

I would be willing to bet that almost every regular reader of RxTrace knows who Bob Celeste is, and most of you have probably already heard that he is ending his long tenure with GS1 US. Last fall that organization announced that Bob would continue into the new year as a consultant, and shortly after that, he would transition his GS1 Healthcare US work group facilitation work to others. Bob reminded everyone on his weekly industry calls of that schedule about two weeks ago and by the end of this month he will no longer fill that role.

Bob started working for GS1 back when Continue reading Thank You Bob Celeste! →

UDI, Uncategorized

UDI Deadline For Class III Medical Devices Quickly Approaching

May 5, 2014 Dirk Rodgers

There 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:

The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
Data for these devices must be submitted to the Global Unique Device Identifier Database (GUDID). § 830.300.
A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014.
Class III stand-alone software must provide its UDI as required by § 801.50(b).

Continue reading UDI Deadline For Class III Medical Devices Quickly Approaching →

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