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

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

Thanks again, Sam. I am relatively new to FDA legislation. I will have a closer look at the performance standard and the other references that you have mentioned.

Cheers
Medgar

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

Sam Lazzara said:

MIREGMGR,
Are you saying that GS1 is looking to verify that the company name in your application matches the Owner/Operator Name in your FDA establishment registration? Otherwise they do not let you join? If so, that is news to me.

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We have an account with GS1 to utilize for pre-EU-UDI barcoding of devices for a Germany-based multinational distributor of one of our product lines that already has warehouse-to-operating-room-scanning of pre-EU-UDI barcodes on their own products and needs to have our products similarly provided with that labeling content. We also use that account for pre-FDA-UDI development interactions on Class II single use drapes/covers with US private label customers.

We market as XXXXXXXXX; that name is our Facility Name in our Establishment Registration, and is a d/b/a. So, all of our customers including the OEMs know us as XXXXXXXXX, and buy from us as XXXXXXXXX. The underlying company is YYYYYYYYY; that name is the Owner/Operator in our Establishment Registration, and has never appeared on any device labeling.

GS1 has refused so far to attach XXXXXXXXX to our account, specifically because it's a d/b/a and they have a policy of not registering accounts to d/b/as. Unfortunately, this means that any human or machine user of the GS1 database that does a look-up on our pre-UDI barcodes gets a responsible-manufacturer name for the (01) attribute that they've never heard of, and that doesn't match the device labeling they're looking at.

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

medgar said:

(...) to determine if any of our products are eligible for exemption.

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Sam has covered the substance. I'll offer one comment: my understanding is that FDA has a provision for exemption just to satisfy the legal beagles, but has every intention of granting very very few exemptions so that UDI will be essentially universal.

There are various reasons for that...more efficient adverse event reporting, for instance...but I think the ultimate driver is strategic communication from the senior strategic planners in the Department of Health and Human Services that universal UDI is needed to provide better data on clinical costs, with a much greater percentage of device costs attributed to specific patient procedures instead of to overhead, so that cost-of-taxpayer-funded-healthcare eventually can be better managed.

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

Has anyone queried FDA yet on how to handle UDI for IDE devices? We just began contract manufacturing a device that eventually will be an accessory for a Class III system, and will be PMAed. Our customer hasn't included UDI in their specified labeling. We have lots of uninformed customers, so I try not to assume that what they direct us to do is regulatorily correct.

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

MIREGMGR said:

Has anyone queried FDA yet on how to handle UDI for IDE devices?

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Investigational devices need not bear a UDI due to general exception per 801.30(a)(6). Relieved? (at least temporarily)

?801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier.
(a) In general. The following types of devices are excepted from the requirement of ?801.20; a device within one or more of the following exceptions is not required to bear a unique device identifier (UDI):
(6) An investigational device within the meaning of part 812 of this chapter.

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

Heh. I hadn't read that very well, obviously. Thanks.

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

A couple updates.

FDA just published its "reader's digest" version of the UDI regulatory requirements. It is called UDI System - Small Entity Compliance Guide (see attached).

Also attached is an article of mine that was published in a recent ASQ Biomedical Division newsletter.
My original "12 steps" have morphed into "14 steps".

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

This is all very helpful yet I'm still having a difficult time wrapping my head around how this will work for a software-only device (no media at all). I'm coming from combination big-iron/software so "scaling down" to a software-only product is a big leap.

I can see how an official software release (like initial release or new features) would get a UDI. What is everyone's opinion (or have you found a ruling from the FDA I haven't found yet) on whether a patch to that release also needs a UDI? My reading of things is telling me that any release needs a UDI, regardless of the changes to the product. Yet, in big iron devices elements of the device can be replaced/repaired and that doesn't change the label. So, couldn't that hold true to a fix to the software, so long as the original intended functionality is intact?

Thank you,
S. Schoepel

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

I am having difficulty understanding the relationship between the labeler and the issuing agency in regards to stand-alone software.

Stand-alone software does not require an AIDC, but does require DI+PI. Does this mean the issuing agency only provides the DI+PI, then the labeler places the DI+PI assigned in the Startup Screen and "About" menu?

I am also unsure of whether a patch would require a new PI.

Any guidance would be appreciated. Thank you!

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

HELP! Can anyone help me and J Mac with our software-only and UDI questions? I'm still not clear on how they should work...see our two questions.

Thank you ahead of time.
S Schoepel