Toxicology

Short answer: the FDA expects a Pre-Submission (Pre-Sub) to clarify risk, regulatory pathway, and evidence strategy—not to pre-approve your device. A Pre-Submission meeting allows companies to ask the U.S. Food and Drug Administration targeted questions about their development plan before investing heavily in studies or submissions.

Short answer: most FDA failures are not created during review. They are created months—or years—earlier during poor planning. By the time a submission reaches the U.S. Food and Drug Administration, the outcome is often already predictable. FDA does not “surprise” companies. Companies surprise themselves by discovering too late that their strategy never aligned with regulatory expectations

Short answer: FDA rejection is rarely about bad data. It is usually about answering the wrong question. Most companies that struggle during FDA review did generate data. They ran studies. They collected results. They invested money.

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