Time’s Up! Mandatory Unique Device Identification Starts September 2015
Come September 24, 2015, all medical device manufacturers of Implants, life-sustaining, and life-supporting devices marketed in the U.S. need to submit unique device identifiers to the FDA.
It’s complex, so please accept this free help from my friends at ReedTech, who have submitted thousands of device records to the FDA.
The live event was 90 minutes due to the sheer volume of questions.
On the agenda:
• Requirements of a GUDID submission system
• Process steps in selecting/launching a GUDID system and making submissions
• Data Fields – including those that are problematic
• Data Cleaning, Harmonization, and Validation tips
• Update on FDA’s changing GUDID Guidance, e.g., convenience kits, Class II Implants
• Lessons learned in setting up a FDA GUDID account and maintaining a record
• Live Questions and Answers
Reed Tech shared your submission options and explained how to make submissions to the Global Unique Device Identification Database (GUDID) before your compliance date.
This webinar is valuable for those upgrading their system used for Class III submissions and for those setting up a new system for Class II and I submissions.
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