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Examples of software changes that required a 510k

SSchoepel

Involved In Discussions
#1
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.)
 

yodon

Staff member
Super Moderator
#2
For the sake of anyone reading and to be sure everyone is on the same page, I presume you are referring to this guidance: https://www.fda.gov/media/99812/download

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?
 

Attachments

SSchoepel

Involved In Discussions
#3
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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