What constitutes a "significant change" in software AND what does not

[DaveDavis]

Hi all,

Greetings, merry Christmas, Happy New Year, etc...

I've the challenge of explaining to my Japanese cohorts what the meaning (definition) of what constitutes a significant change in software (hardware as well, but let's focus on software). We are a medical device manufacturer and therfore follow all FDA guidelines and laws... blah, blah, blah. I gave them the examples cited by FDA - the unfortunate issue is that my counterparts take those examples as literal and not "examples". I've found that being to verbose is NOT a good thing with the Japanese, so I need to try and be a little less wordy and provide more examples.... That's why I'm asking for your help.

I would like to ask you for your interpretation of what constitutes a "significant change" in software AND what does not.

Thanks for your help...

Dave

 

[tarheels4 - 2007]

I would like to ask you for your interpretation of what constitutes a "significant change" in software AND what does not.

Thanks for your help...

Dave

Definition "Significant Change" What you would get if you could develop software to compete with Microsoft windows.

Sorry, just joking, I don't know what it means. :truce:

 

[tarheels4 - 2007]

I googled and found this link.
https://www.gnu.org/prep/maintain/html_node/Legally-Significant.html

 

[Microbe]

European Definition

Hi,

Not sure if this helps much, but this link goes to a European definition from the Notified Bodies

<<Dead Link Removed>>

Not sure about software, but it has always seemed a grey area to me. I've always taken it on a case by case basis. Not sure about the FDA - bvut with our Notified body, I call up and ask if in doubt.

Regards

Microbe

Moderator Edit: Try this
https://www.tuvamerica.com/tuvnews/newsletters/pdfs/nbdesignchanges.pdf

 

[Jim Wynne]

I would like to ask you for your interpretation of what constitutes a "significant change" in software AND what does not.

I'm not an expert in FDA stuff, and I don't know if there's an official definition, but I'll take a stab at it subject to correction by one of our real experts.

A significant change might be:

• One that adds or removes user features/controls/functionalities
• One that affects basic logic algorithms such as branching and thus might affect other parts of the program unexpectedly
• Bug fixes

An "insignificant" change might be:

• Addition of remarks or comments
• Changes that don't affect program function such as cosmetic interface changes (changing the color of a screen background or changing a displayed font, e.g.)
• Rearrangement of displayed interface elements without adding or removing elements

 

[Al Rosen]

Hi all,

Greetings, merry Christmas, Happy New Year, etc...

I've the challenge of explaining to my Japanese cohorts what the meaning (definition) of what constitutes a significant change in software (hardware as well, but let's focus on software). We are a medical device manufacturer and therfore follow all FDA guidelines and laws... blah, blah, blah. I gave them the examples cited by FDA - the unfortunate issue is that my counterparts take those examples as literal and not "examples". I've found that being to verbose is NOT a good thing with the Japanese, so I need to try and be a little less wordy and provide more examples.... That's why I'm asking for your help.

I would like to ask you for your interpretation of what constitutes a "significant change" in software AND what does not.

Thanks for your help...

Dave

Is the purpose of determining what constitutes a significant change for determining whether to submit a 510(k) premarket notification? A significant change in the FDA world may not be considered significant in the general sense and the result of the change on the device as well as the labeling must be considered.

 

[DaveDavis]

A little more nfo

Is the purpose of determining what constitutes a significant change for determining whether to submit a 510(k) premarket notification? A significant change in the FDA world may not be considered significant in the general sense and the result of the change on the device as well as the labeling must be considered.

Hmmm, let me see if I can clarify:

I understand what constitutes a "significant change" to FDA (they have a published guidance)... but what I was looking for is examples that I can put into a table to demonstrate significant and non-significant changes - according to FDA & industry.

FDA states:
(i) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.
(ii) A major change or modification in the intended use of the device.

... and they provide some examples; like AC to DC or Analog to digital, etc...

But I was looking for more "real world" experiences and examples.

Thanks again.

Dave

 

[VitaliKravitzki]

Significant changes to software

Hi, guys

I totally disagree with depending significant changes on number of alternated code lines.

Allow me to suggest following list of cases when the recent changes in software were significant:

1. New module added - the one that is related to more then one existing module
2. Design (spec)-change implementation
3. Per-customer localization (perhaps, always...)
4. Infrastructure bugs were fixed
5. After "war-room" situation - (any major issue found by customer and solved as fast as it gets...)
6. Any time at least regression test required (NOT PLANNNED ) - sometimes it is easier to know that regression is required then whether the change was significant, BUT there's always a connection between them ...)

Regards,
Vitali