Motivation Back in the Fall of 2022, I watched the 2018 documentary The Bleeding Edge1, which investigates the FDA's medical device clearance process. I was surprised to learn that for many devices, clinical trials are not required. The documentary scrutinizes the FDA's 510(k) clearance process, through which some devices can be fast-tracked for use if they are "substantially equivalent" to an existing device, even without a clinical trial. Several of these devices even led to patient injuries i...