To understand why these rules are such a problem, consider the FDA’s “premarket notification” guidelines for masks. First, you must describe the device and its intended use, including drawings, for which you will want to hire someone with fluency in bureaucratese and knowledge of the various regulations. Then, you will need to hire a team of materials scientists and medical researchers to perform a series of tests on your prototype masks. They will need to make “side by side” compositional comparisons between your mask and all masks currently on the market. You must prove that each of the hundreds of individual choices made when designing your masks — from any of dozens of different kinds of fibers, patterns of weave, color, type of elastic, and such — will enhance its “comparative safety and performance.”