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Direct answer: most medical devices do not fail FDA review because the science is weak. They fail because the strategy was weak. In many cases, the engineering works. The bench testing looks solid. The prototype performs as expected. But the submission fails because the development plan was not aligned with how the U.S. Food and Drug Administration evaluates risk, evidence, and benefit

Short answer: marketing similarity is not the same as regulatory substantial equivalence. Many founders believe that if their device “looks like” something already on the market, they can file a 510(k). That assumption is one of the most common regulatory mistakes in medical device development.

Short answer: when a team says, “We’ll try 510(k),” it usually means the regulatory strategy is not fully developed. A 510(k) is not something you “try.” It is something you qualify for. Under the framework of the U.S. Food and Drug Administration, the 510(k) pathway depends on a very specific standard: substantial equivalence to a legally marketed predicate device. If that logic is not solid, the pathway collapses.