Category Archives: UDI

FDA Proposed UDI: A Revolution In Number Assignment

Like so many others, I had been patiently awaiting the publication of the U.S. Food and Drug Administration’s (FDA’s) Unique Device Identification (UDI) proposed rules.  Now that they are out I’ve been studying them and I think I will have enough to say about them that I will cover the topic in a multi-part series.  Today I want to look at just one of the differences between the FDA’s proposed UDI rule for medical devices and their National Drug Code (NDC), the pharmaceutical unique identifier.  The NDC structure was first conceived by the FDA back in 1969.  For more about the history of the NDC see my essay “Anatomy Of The National Drug Code”.

The thing I find fascinating is that at the same time they created the NDC for drugs back in 1969 they also created a comparable identifier for medical devices.  They called it the National Health Related Item Code (NHRIC).  Both the NDC and the NHRIC were voluntary until 1972 when the FDA made Continue reading FDA Proposed UDI: A Revolution In Number Assignment

A Quick Note About The UDI Conference September 18 & 19, 2012

The FDA is co-sponsoring an important two-day conference in Orlando on September 18th and 19th, 2012 that will cover their plans for medical device Unique Device Identification (UDI).  Today is the last day to get their early-bird registration rate of $695 so act fast.

But I know a way to get another $100 off of the early, the advance and the standard registration fees.  When you register, simply put the letters “RX” in the “Promotional Code” field of the registration form.  That lets them know that you are a special RxTrace reader and deserve to pay less.  Remember, it works on all registration levels.

I’m going to have a lot more to say about the FDA’s UDI proposed rule in the coming weeks but Continue reading A Quick Note About The UDI Conference September 18 & 19, 2012