An organized group of healthcare interests including doctors as well as hospitals and consumer groups recently sent a letter to the Food and Drug Administration saying it is high time that regulations covering Unique Device Identification (UDI) were finalized and known and that the FDA has taken too much time to reach some definitive resolution.
This according to Julian Pecquet, writing for the Healthwatch section of The Hill’s Healthcare blog: The letter points out that more than 700 medical device recalls were issued in 2008. It says the FDA has taken an “unreasonable amount of time “to publish proposed regulations since it was required to do so in 2007.”
GS1 is not specifically mentioned in the news report, but it is a prominent part of the actual letter. The very fist sentence of the very first paragraph says this: …we write to urge the Food and Drug Administration (FDA) to issue a proposed rule immediately that establishes a unique device identification (UDI) system that supports both national and global needs through the GS1 system.
The organization responsible for the letter is called the Advancing Patient Safety Coalition. The news story about their letter is here. And the full text of their letter is available at this link. Not that it probably matters, but I find it interesting that GS1 is not listed as one of the coalition members.
GHS and Regulatory Labeling Challenges in the New Era 
