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→
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 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 missed my self-imposed Monday deadline for an RxTrace essay this week because I am still recovering from the Pelotonia cancer research fundraiser bike ride that I participated in over the weekend. This year I roused the necessary donations, plus my own contributions, to be able to ride the full 180 miles over the two day event.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.