US FDA Unique Device Identification (UDI) Proposed Rule

[sreenu927]

Hi All,

US FDA has released a proposed rule on Unique Device Identification (UDI). It’s scheduled to be published in the Federal Register next week, but can be viewed from the link provided in the FDA website (also I hv attached here).

A link to FDA’s page on UDI is here

http://www.fda.gov/MedicalDevices/De...ce=govdelivery

The GHTF issued UDI system recommendations in 2011, emphasizing the use of global standards so that UDI data can be shared across medical device markets.

Also, you might be aware the IVD Directive is going to be a "Regulation" soon with changes implemented somewhere in between 2014-2015, also have some information on implementation of UDI.

I am not sure, whether the proposed FDA UDI system has incorporated those GHTF recommendations or not, as it is 165 pages, I didn't go through the document.

You can submit your comments, if any on this.

Regards,
Sreenu

[Gert Sorensen]

It is going to be very interesting to see if this is going to be the trendsetter for device identification, or if it is going to be one of various systems. I do hope that we will only have to handle one system for this issue.

[lfrost]

It is interesting that the proposed rule was released on July 2, 2012 and will be published in the Federal Registar sometime next week. Then will the comment period start. The biggest aspect of the rule is the "phased-in" process of the UDI system. After the Final rule is published, Class III manufacturers will have one year to become compliant with the rule. Three years after the final rule is published, Class II manufactures will need to become compliant. Class I manufactures will have five years after the final rule is published to become compliant. Interestingly, Class I manufacturers are the only ones that can obtain an exception to the rule if they already have UPC codes on their product and they are sold "over-the-counter" without prescription.

The actual proposed rule is the last 46 pages of the publication. The rest is the background that FDA went through to reach the proposed rule changes for UDI.

I have skimmed the proposed rule, and am also hopeful that the system which is finalized, becomes a standardized system which can be then adapted to all regulatory agencies so there is only one system of labels!

[Ronen E]

CDRH Learn new module on UDI:

http://www.fda.gov/Training/CDRHLear...ovdelivery#udi

[lboll]

The new FDA UDI proposal requires the expiration date to be formatted as MMM DD, YYYY with the month as 3 letters.
The MDD requires the expiration date as year and month, which we interpreted as YYYY/MM.
As a small company, we use 1 label for all devices regardless of where they are sold.
It appears as if we'll need to put the expiration date on our labels now in 2 different formats.
Is this how others are approaching the issue?

[klong483]

I made a short summary (attached) that might help explain it to your non-regulatory colleagues.

Cheers

[lfrost]

In Reply to Parent Post by lboll

The new FDA UDI proposal requires the expiration date to be formatted as MMM DD, YYYY with the month as 3 letters.
The MDD requires the expiration date as year and month, which we interpreted as YYYY/MM.
As a small company, we use 1 label for all devices regardless of where they are sold.
It appears as if we'll need to put the expiration date on our labels now in 2 different formats.
Is this how others are approaching the issue?

You must remember that this is a proposed rule and not a finalized one. There is a 120-day comment period (which began July 10, 2012 when the proposed rule was published in the Federal Registar. This period is the time for you to comment with the rules that conflict with your current procedures. If you don't want two labels, then tell the FDA that two labels would be hard for you to do as well as a financial burden. Maybe they will change the rule to harmonize with the MDD dating as year and month.

I know it is wishful thinking, but now is the time that we have to see if we can change the FDA's thinking that some of the portions of the rule would bring about financial burdens on those small manufacturers of medical devices. My company is one that will have three years after the final rule is published before we have to comply because we manufacture class II devices.

[Wanni]

I have a generall question in regards to the UDI Code. We already use GS1-128 and EAN-13 Code for our Medical Devices. Since we use this kind of codes already, what is the next step to fulfil the UDI requirements?

Looking forward for some help

Thank you in advance