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New Developments in FDA Regulation of AI

April 9, 2020

An excellent summary and analysis of FDA actions on AI over the last year. Most of the attention thus far has centered on premarket certification, whereas the post-market pieces are still in motion. Looking at it from an assurance lens, a couple of key takeaways jump out:

  1. Since radiological devices are the tip of the spear, they're likely to shape regulatory thinking across devices and applications in the future.
  2. Groups are focused on ensuring quality inputs, an important issue, but not enough attention has been paid to the transparency and validity of the outputs.
  3. Since safety is less evident premarket, the burden of proof must shift to postmarket reporting.
  4. The FDA will need to consider how to minimize the reporting burden in order to maximize the positive impact of AI/ML on population health.
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AI Governance & Assurance
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Regulation & Legislation