Hello,
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 https://www.tapatalk.com/topic/4433...s-that-require-use-of-a-new-device-identifier
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!
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 https://www.tapatalk.com/topic/4433...s-that-require-use-of-a-new-device-identifier
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!