Hello Anon,
This question is asked quite often on this forum, you could probably search to find other posts. There is no magic formula for cumulative effect of changes because one change with one other change may result in a significant change or it may take 10 changes to result in a significant change. You should refer to the FDA guidance on changes to software in relation to 510(k) submissions:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-change-existing-device which gives some examples. If you internally determine a new 510(k) needs to be submitted, then you should not market the device until the 510(k) is cleared. Now if there are already changes made, you have to determine internally when the switch-over should occur using all available information. You do not want to get stuck in a situation where the FDA is telling you a 510(k) needs to be submitted as often this means marketing the product may need to be suspended.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-Feb-2021 09:59
From: Anonymous Member
Subject: Software changes - LTF to 510(k)
This message was posted by a user wishing to remain anonymous
Hello,
How do you decide the cumulative effect of a number of LTF (number of changes) and whether these exceed the regulatory threshold for documentation and warrant a 510(k) ? Additionally, if it is determined that the cumulative changes warrant a 510(k) is there a concern for keeping the product on the market while submitting the 510(k)?