Have you been wondering what has been going on with the Unique Device Identification program that the FDA is in the process of introducing? You are not alone, there has been very little news on the program and many in the Auto ID industry have been thinking that the idea is being dropped.
There is a small sign that things are going on behind the scenes however, the FDA is hosting a public workshop called “Unique Device Identification (UDI) for
Postmarket Surveillance and Compliance Public Workshop”
This is being held on September 12 and 13th in Bethesda, MD and will also be Webcast live.
What is really interesting is that the event website states:
“This public workshop is NOT going to discuss the UDI proposed rule or regulatory framework for UDI.”
Clearly the FDA UID rule is going to remain a closely guarded state secret for some time to come – maybe those that say the unique part of UID has been dropped are correct.
Anyway, if you want to take part in this workshop, either at the location or online, you can sign up here – if you go to the actual event, you can get a packed lunch for $15 as well!
Do you work in the medical device business? What steps (if any) has your company taken to get ready for the UDI marking rules?