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:
RxTrace 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→
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→
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→
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