Class II Medical Device Unique Device Identifier (UDI) Requirements

I have been reviewing and attending seminars on the new UDI requirements. Fortunately we are a class II device so we have 3 years from the date of final approval of the rule, expected (by congress) May 2013.

This seem to be fairly complex especially for companies who have multiple locations around the world and/or a large number of products. It will take top level planning, strategy and lot of data checking.

The UDI number will tie the device PMA/510k, listing number, establishment registration number and eventually post market information about the device.

UDI numbers will also need to be updated periodically as a result of a regulatory event.

It will be important to get this all right or could be a very bumpy road, not to mention an incorrect UDI could be considered an adulterated device by the FDA.

So I would like to open a thread for people working on this to share thoughts, ideas and problems in countered.

Remember the "Comment Over" date for the draft rule 21 CFR Part 830 in November 7, 2012. Congress is urging for the final rule by May 2013

A Quick Bump!

Can someone help?

Thank you very much!!

Good idea.
Like you, we also design/manufacture Class 2 devices. We also design/manufacture Class 1 devices.
With the number of products that we have and the fact that we have acquired many companies over the last 30 years all over the world, our identification is not standardized. Sure, we have procedures that drive our core labeling and traceability activities, but bringing the other companies into the fold continues to be a challenge. That said, traceability for recalls should be easier.

Will the Direct Part Marking provision affect your company?

Thank you and good to hear from you rogersr12.

Yes we will be adding a UDI label to each device. We manufacture over a 150 models with approximately 500 different configurations. At this point we are looking at labeling the main models only as the different configurations are mostly accessories and can be added later in the field.

Like you we have acquired many companies and our products depending on model and manufacture name are manufactured in many different countries.

I think this will take a lot of strategy to meet the requirements across all companies and across all markets.

Does the UDI tie to a version of the product?
For Software devices, this could be a large problem.
We can go several 'versions' of the software without affecting the intended use...not to mention updates in between versions.
Any concern on this at all?

The Comment Period doesn't close until November 7, so nothing's set in stone. That said, unless the software is stand-alone software (and is a medical device under Section 201 of FDCA), it is not subject to UDI.

In case it helps, a link to the proposed rule is below. Jump down to Section 801.35 and the rule tries to answer some pertinent software questions. Hopefully those will help you. If not, some of us can also give it a shot.

http://www.gpo.gov/fdsys/pkg/FR-2012-07-10/html/2012-16621.htm

Regards,

Bob

I put in Comment 1jw-81gl-nxm3, on required date formats.

Anyone with concerns should read the Proposed Rule and submit a Comment.

How does UDI assigned? Does FDA assign the code?
I have been reading proposed rule and FDA said they are using accerdiated agencies for the purpose but I am not sure if this is the case for GUDID or manufacturer needs to put all device specific information and FDA would geenrate unique identifier for that particular version/model of the device?

Please help,

Thanks

IVD_RA

The FDA is not assigning code nor do they want to tell what code you must use other then it must be a recognized standard. That leaves you with GS1, HIBCC or ICCBBA. They all have pluses and minus's but probably the most important is the code accepted in the countries you sell to, they are not all equal. This is part of the reason that this is a corporate strategy not just a departmental decision.