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UDI "Version or Model" for Stand-Alone Medical Device Software

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  Post Number #1  
Old 26th September 2016, 12:54 PM

Total Posts: 36
Please Help! UDI "Version or Model" for Stand-Alone Medical Device Software

We have a Class II stand-alone software device. This device is web-based and has no components in which a physical label could be placed. All updates are applied through the web and users cannot control the "version" used. Every couple weeks we release a new version of software that fixes certain bugs, adds features, etc, all within the defined Indications for Use.

Are we to obtain a new DI for every software release? Everything I've read indicates the DI must change along with changes to "versions of models". This all depends on how you interpret "versions or models". When looking at 21 CFR 801.3, "version or model means all devices that have specifications, performance, size, and composition, within limits set by the labeler". This doesn't seem helpful except for the hint that this threshold is defined by us, the labeler(?)

I've only found one other source online with a discussion relating specifically to this for what it's worth

Would you agree that our DI would stay the same for new releases as long as we stay within the boundaries of our 510k? - With this, our PI would be revised every release, as our manufacturing date is reflected in our software version number in our "About" section.

Hope that makes sense. Thanks!

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  Post Number #2  
Old 26th September 2016, 01:45 PM

Total Posts: 35
Re: UDI "Version or Model" for stand-alone software

My company also produces standalone software that the customer receives via an electronic installer. We have interpreted the GUDID guidance consistently with your own - that is, the PI changes with each release/version (which is the Batch/Lot number for FDA GUDID purposes) but the DI does not change unless there is a significant enough change to warrant a 510(k) submission. We've updated our relevant procedures accordingly.

As you noted, FDA leaves it to the labeler to determine whether device upgrades or variations constitute different models or versions. That seems key, in that FDA commentary indicates they believe this, combined with the definition you quote and the language of section 820.50, addresses industry concerns that each software update would require new a UDI. See the commentary on final rule in the Federal Register published 09/24/2013 - you can search for "820.50" or "software" and skip to the relevant sections. Apparently I can't make a direct link to the rule online since I have not posted enough here - sorry.

If we're wrong, we'll be wrong together .
Thank You to DEVigil for your informative Post and/or Attachment!
  Post Number #3  
Old 26th September 2016, 01:54 PM
Mark Meer

Total Posts: 891
Re: UDI "Version or Model" for Stand-Alone Medical Device Software

IMO, I think your system is fine.
If you use a Major.Minor version system, I think it would be justifiable to simple state that the DI "Version" simply applies to the major version level (e.g. DI = version 1.x of the software).
...and then, as you say, just update the PI with each minor revision.

Only when there is a major revision, you'd make a new DI.

NOTE: Just my input for the purpose of discussion (I, unfortunately, have no authoritative references to refer you to, but this seems reasonable...)
Thanks to Mark Meer for your informative Post and/or Attachment!
  Post Number #4  
Old 4th October 2016, 09:34 PM

Total Posts: 201
Re: UDI "Version or Model" for Stand-Alone Medical Device Software

that is my approach too.

If you search for other software devices, you'll notice that under "Version or Model" some actually don't define a specific version, but rather list the model name of the device.
If you supply your software on a media, that will probably not work though.
  Post Number #5  
Old 25th May 2017, 05:50 PM

Total Posts: 39
Re: UDI "Version or Model" for Stand-Alone Medical Device Software

I know this thread is old but I'm hoping those on it or someone who finds it knows the answer. (I asked the FDA help desk but just got quoted regulations.)

I am trying to set up the product in the GUDID. It says there can only be one DI and for each product you need a new DI. We have standalone software and are using a model number with our business identified in the DI and putting the major.minor release in the PI.

Can I enter each major.minor release we have in the GUDID using the same DI (though it says you can only use it once)?

For example we would have:
DI = INC123DeviceModel1
PI = xxxx16xxxxx
(pretend the xxxs are the other parts of the PI and 16 is for release 1.6)

If I have release 1.7 or 1.8 or 3.0 and none of them change our intended use but I need to enter the new UDI, I would be reusing the DI. That reuse seems to go against the user guide for the GUDID interface.

Have you entered more than one product release under the same DI in the GUDID?
  Post Number #6  
Old 3rd August 2018, 08:17 PM

Total Posts: 1
Re: UDI "Version or Model" for Stand-Alone Medical Device Software

Did you find the answer to your question? I have the same question
  Post Number #7  
Old 7th August 2018, 10:02 AM

Total Posts: 39
Re: UDI "Version or Model" for Stand-Alone Medical Device Software

Nope. I have been bumping the DI number by one digit to match the major revision level just in case. We only have one product and not very many releases so this is sustainable for a while.

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