If you are part of an organization developing or producing Class II medical devices, you should know that on September 24, 2016, your UDI submissions are due to the FDA.
“I don’t mean to scare anyone, but we only have 78 working days left.” - Gary Saner
UDI stands for “unique device identification,” and the new labeling regulations have been put into place to increase patient safety, reduce medical errors, and provide a foundation for secure global distribution of devices.
Today’s guest, Gary Saner, is an expert on UDI submissions and other regulatory topics. As the Senior Manager of Information Solution at Reed Tech, Gary is speaking to us today about the UDI submission procedures and other relevant topics.
“The UDI submission is not a one-time effort.” - Gary Saner
With over 30 years’ experience in software management and data conversion, Gary is the go-to person if you have questions about UDI, and his company can help medical device companies of any size be sure that their submissions are in order.
Some of the topics you’ll hear discussed on today’s podcast include:
What UDI is and what information needs to be included in each of its components.
The timeline of deadlines leading up to now and up to September 2016 as they pertain to different types of devices.
Some of the challenges that apply to larger and smaller companies when it comes to meeting the 9/24/16 deadline, as well as how the Reed Tech tool can help organizations of all sizes.
The importance of knowing and understanding the UDI submission process.
The two submission methods that the FDA has in place.
Tips and pointers to keep in mind as you go through the submission process.
Links and Resources
About The Global Medical Device Podcast:
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.