This is very interesting. At the FDA News web site you’ll see a brief item entitled, “Devicemakers Question Data Requests for FDA’s Prototype UDI Database.” The first sentence seems to imply there may be much work ahead to finalize a UDI approach that satisfies everyone. The sentence is: Devicemakers testing a unique device identifier (UDI) database say the prototype required information that may be proprietary, unnecessary or not always readily available…

While you can’t see the Devices and Diagnostics Letter that is offered via a link at that page unless you’re a subscriber to the site, there is a freely available FDA report on the matter. The report, which is here, I think you will find very interesting in terms of all the specific preferences, challenges and questions the participants faced during this pilot. If you’re in the medical devices business, you’re probably trying to work through these same concerns. To that point, don’t forget about our next UDI webinar in our five-part series. It happens January 12th and you can register for it here. Or if you can’t wait and want to get a head start on UDI compliance, call 603-766-3630. The FDA article can be read fully here

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