Over the last five years the larger companies in the U.S. pharmaceutical supply chain have increasingly aligned around GS1’s Electronic Product Code Information Services (EPCIS) standard for holding and communicating serialization-based events. The hope and expectation by many of these manufactures and others in the supply chain is that EPCIS will be the standard that ensures supply-chain-wide interoperability in any future track and trace or ePedigree system that the federal government might impose. On its surface it appears that EPCIS is designed around GS1’s family of serialized identifiers, which are based on GS1’s GS1 Company Prefix (GCP) (see “Anatomy of a GTIN” and “Your GS1 Company Prefix: An Enterprise Resource“). This includes Continue reading Will Use Of EPCIS Force Everyone To Use GS1 Identifiers?
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
The 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
The 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