Including Machine Learning Algorithms in 510(k) submissions

  • 26 August 2022
  • 0 replies


I am working on a 510(k), which would introduce some machine learning models into the data processing pipeline of our software (which is part of a medical device, not SaMD). 

We did have a pre-sub meeting with the FDA, and they seemed to want a huge amount of details related to every possible aspect of the data collection and algorithm development.  I am trying to write up the description now. 


I was wondering if anyone has successfully submitted a device that includes machine learning models and how it went. Is there any advice I could use to hopefully not get a million questions back from them after submission. 


Also, on a curiosity point, we opted not to submit with a Pre-Specified Change Control Plan, as that would have required us to use the De Novo pathways. 


Thanks for the help!


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