FDA's Risk-Based AI Guidance Hands Sponsors the Validation Bill
The Clinical Trial Vanguard reports that FDA's risk-based AI guidance shifts the validation burden to sponsors. I'd argue that burden was always theirs, and the guidance just removes the illusion that a regulator or a vendor would carry it. Risk-based sounds lighter until you realize someone has to decide what counts as high risk and then defend that call later. In every governance committee I've sat on, that classification step is where programs stall. Sponsors who already run evals and keep a clean model inventory will barely notice. The ones relying on vendor assurances are about to learn what they actually own. Who signs your risk tiering today?
Source: FDA’s AI Risk-Based Guidance Shifts Validation Burden to Sponsors - The Clinical Trial Vanguard (The Clinical Trial Vanguard)