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:
- Since radiological devices are the tip of the spear, they're likely to shape regulatory thinking across devices and applications in the future.
- 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.
- Since safety is less evident premarket, the burden of proof must shift to postmarket reporting.
- 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.