Clarity is not so easily obtained (even for the most experienced) when assessing software that functions as a medical device. Developers looking to commercialize their products want and need to understand if their product is a regulated device subject to the FDA’s 510(k) clearance process. If a product is a regulated medical device and a developer fails to obtain FDA clearance, a developer could find themselves on the wrong side of FDA enforcement because the product will be considered misbranded upon commercialization into interstate commerce.
