2 min reading time

UDI regulations kick in for Class I and II devices in 2015.

So let’s start the year with a free webinar for ways to make your UDI submissions easier.

http://medgroup.biz/UDI-in-2015

Reed Tech is my go-to on this subject. They’ll cover:

• 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 and implants
• Notes in setting up a FDA GUDID account

The live event is January 21 at noon Eastern Time but the video replay, slides, and transcript will be made available for all who register.

For today’s discussion, a question for the Class III manufacturers who submitted in 2014.

Do you advice to give the group from your experience? Maybe some “watch outs?”

We’ll take questions on the live call. Register at http://medgroup.biz/UDI-in-2015

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SPEAKING OF WEBINARS

Did you know we archive each Medical Devices Group webinar for later playback?

See http://MedicalDevicesGroup.net/webinar for replays, slides, and transcripts for content dating back three years!

Most recent addition: Video/slides/transcript for “How Medical Device Websites are Evolving” at http://medgroup.biz/device-sites

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RECENT DISCUSSIONS

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Are “better outcomes” smoke and mirrors?

A good template for a Class I recall?

Will Sony finally scare you into action?

How to make a value analysis committee process easier?

Are device manufacturers concerned about packaging quality?

Does “Value” mean “Low Price” for Medtech?

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. Our Super Bowl pool. Winner gets one free 10x admission: http://medgroup.biz/superbowl

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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
I do not know but Gary will. Join us at the webinar! It’s free.

Joanna Harris
Sales Manager at HHS
Joe, AdvaMed presented to the FDA last August “UDI Challenge for Non-Sterile Implantable Devices”. Companies that presented included DePuy-Synthes, Stryker, Smith & Nephew, and Medtronic. The purpose of the presentation was to ask for an extended delay in implantation of UDI on non-sterile implants. However, I cannot find any information with regards to the FDAs response to AdvaMed’s request. Do you know if the FDA approved the request? Thank you, Joanna

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Apologies: I made a mistake and, thankfully, a reader brought it to my attention.

The UDI regulation for class II devices takes effect in 2016, not 2015. In fact, the FDA will not even accept applications until later this year so those companies can begin listing their devices.

The corrected statement, then:
UDI regulations kick in for Implantables and Class II devices in 2015.

I apologize for my error.