The FDA Wants Your AI Validation Written Before You Use It
What stands out in the FDA's draft guidance is the timing. Sponsors have to show how they assessed a model's fitness for its specific use before they used it, and that record is hard to produce after the fact without it reading like a reconstruction. The exposure sits in the quiet tools, the risk-based monitoring and data quality flagging that teams adopted fast because they felt like helpers rather than decision makers. In the governance committees I've run, those were exactly the tools nobody had inventoried. With an April warning letter already citing AI misuse, can you list every model that touched your submission data?
Source: FDA’s AI Risk-Based Guidance Shifts Validation Burden to Sponsors - The Clinical Trial Vanguard (The Clinical Trial Vanguard)