12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015)

[Laura S]

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

As a modification to the QSR, companies need to modify their forms and templates to capture UDI information in their post-marketing feedback systems.

 

[SSchoepel]

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2014)

Thank you for responding when I asked for more help. I believe our question wasn't whether we had to record the UDI, but how it will be assigned for software-only devices.

For software-only devices:
1. How would the number be created (since we wouldn't technically have batches/production)?
2. What would trigger a new number (having to do it for every patch or every major release)?

Regards,
S Schoepel

 

[ScottK]

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2014)

This is a really good article.

Does anyone who supplies a devices to distributors feel that any distributor is pushing your towards GS1? I've got a couple - one of whom sent an interesting letter only referencing GS1 standards and not once referencing FDA requirements.

I told one distributor that we haven't settled on one yet and he said "But we need you to use GS1". So I said "But what if we have another distributor that wants us to use HIBCC?".
no answer...

Fortunately we have a couple years on the FDA timeline to still figure this out since we're all Class I.

 

[drewsky1]

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2014)

Is the UDI only applied to the label for those packages that go directly customers and distributors? What about overshipper labels that may come from the supplier of finished goods to our (Mfr) distribution center?

Thanks

 

[Ronen E]

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2014)

Is the UDI only applied to the label for those packages that go directly customers and distributors? What about overshipper labels that may come from the supplier of finished goods to our (Mfr) distribution center?

Thanks

A.5. Question: What is a device package?
For purposes of UDI label and GUDID submission requirements, a device package is a package that contains a fixed quantity of a particular version or model of a device. In order to adequately identify a device throughout distribution and use, the various package configurations, i.e. each different type of package, must have a unique identifier, 21 CFR 801.20(a)(2). Thus, if a device is sold in individual device packages boxes of thirty (30) devices, and in cartons that contain twelve (12) boxes of thirty (30) device packages, a different DI would be required to appear on the individual device package, on the box of thirty packages, and on the carton of twelve boxes of thirty device packages. See Section 3.1.2.1 of the Guidance titled “Global Unique Device Identification Database (GUDID)” issued on June 27, 2014, for more information.

http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM410439.pdf

 

[cmeby]

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2014)

These are good questions from S Shoepel, and I am also looking for the answer regarding Software Only Devices. Has someone done this yet?