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Examples of software changes that required a 510k


Involved In Discussions
Could anyone share examples of the types of changes you made or you know of being made that required a new 510k submission? Even stories where it was found later in an audit that a change should have been a 510k submission? I'm trying to give appropriate guidance to staff here and more examples would be helpfulf. (Yes, I have the guidance documents but even with those you can argue interpretation.)


Staff member
Super Moderator
For the sake of anyone reading and to be sure everyone is on the same page, I presume you are referring to this guidance:

Some probably obvious ones:
  • Adding new functionality
  • Expanding the scope of use (beyond initial claims)
  • Changes introduce new risk
  • Adding new roles or users
Do note that as individual changes are rolled out, they may not, in and of themselves trigger a new 510(k) but the accumulation of changes should be considered as well. Have the accumulation of changes met any of the trigger requirements?



Involved In Discussions
Right, I have the guidance and I get those generic examples. What I'm looking for is anyone willing to share specific examples. I get the obvious ones like: we moved from C to Java and had to rewrite the entire software app on the device. What I'm looking for is other stuff. For example, has anyone moved from a home-grown UI handler to Windows UI handlers and had to do a new submission. Or things you were on the fence about and after talking with the FDA (or notified body even), you discovered they considered it a change worthy of a new submission.
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