Yesterday, Reed Tech UDI experts Gary Saner and John Lorenc held a live UDI Q&A session for Class II medical device labelers. There were dozens of questions from the audience and our panel was unable to answer all of them during the time allotted, but here are a few they tackled during the session:
I sent my application to the FDA to create a production account on February 5th and they have not responded. How long should it take to get an account set up?
How are Class II device accessories affected by UDI?
If I start now, how long will it take to get the work done to label a Class II device with UDI by September?
Who uploads the DI into the GUDID database, us or the contract manufacturer that ships us the finished product?
To hear Gary and John’s answers to these questions, you can visit our website and access the recording of the entire webinar. You can also download the presentation slides.
If you were unable to attend but have UDI questions, or if you were on the webinar but we ran out of time before answering your question, please contact us. Our experts will be happy to help you.