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:
The title is a paraphrase of a TV commercial from the 1960’s, ’70’s and ’80’s for Lay’s Potato Chips but the sentiment is the same. You really can’t get away with using only a single GS1 standard. That’s why they are sometimes referred to as “The GS1 System of Standards“. It’s a “system” of standards. Multiple standards that are designed to work for you together in concert; as a whole; not independently.
I want to thank everyone for reading and commenting on RxTrace in 2010 and wish you all HAPPY HOLIDAYS and a HAPPY NEW YEAR. Due to our family party schedule I don’t expect to post any more essays this year.
I’m planning to see a number of movies in the next few weeks with my wife, two daughters and son-in-law. One of our favorite holiday activities is to debate which ones to see. Debating with my kids is probably what it must be like debating with me, but in the end we all have fun and always have a lot to talk about (and Dad pays).
So drive carefully, don’t drink and drive and don’t eat too much. On the other hand, do make peace with your family members, sing a lot, say thanks to members of our armed forces and give to charity. And, OK, you can eat too much just once.
The effort to create the business and technical requirements for Discovery Services started just about two years ago and completed this past December. How long will it take to get to a ratified standard? The GS1 Discovery Services Work Group Charter predicts it will be done in June of 2011, but predictions in charter documents are notoriously optimistic. The EPCIS Charter predicted that standard would be ratified in August of 2005, for example—one third the time it actually took.
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.