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What does the FDA think about LLMs?

Insider tips and more

Let us walk you through an example medical device that includes a large language model as a key component. The same questions and insights also apply to radiology foundation models. You'll get answers to questions like:

  1. Is synthetic data permissible?
  2. Is fine-tuning permissible?
  3. Does the algorithm need to be run offline?
  4. What if the outputs are not fully deterministic?
  5. What if the provenance of training data is not known?
Large language models FDA