7 ms·
As an FDA law firm engineer, I review and submit about three AI devices a week to FDA (Ive probably done at least 50 AI submissions at this point) As part of
by 5440 6y ago
As an FDA law firm engineer, I review and submit about three AI devices a week to FDA (Ive probably done at least 50 AI submissions at this point) As part of that I review the all the submission docs including the design specification for each submission. Im convinced that none of the companies understand how any of the math works and they just submit models they have grabbed from Tensor or Pytorch
- mola 6y agoI can't say that I'm surprised, but I really appreciate your comment. This sort of "inside information" is immensely valuable for society, especially in a world consumed with PR. Whenever people talk about making the FDA less strict I get shivers down my spine. Was the snake oil salesmen really a better medical institution?