Toxicology

By Harriet Kamendi | Regulatory Toxicologist | Kandih Group Imagine you are a founder. You have compelling efficacy data, a clean mechanismof action, and enough runway […]

Short answer: Pre-Submissions (Pre-Subs) often fail not because the science is weak, but because the wrong regulatory questions were asked. Many companies approach a Pre-Submission thinking the goal is to prove the device works. In reality, the goal is to align the development plan with the expectations of the U.S. Food and Drug Administration before major investment decisions are made

Short answer: investors often interpret FDA Pre-Submission feedback as a signal of regulatory maturity and execution risk. A Pre-Submission (Pre-Sub) is designed to align a company with the U.S. Food and Drug Administration before a formal submission such as a 510(k), De Novo, or PMA.

Short answer: during a Pre-Submission (Pre-Sub), the FDA focuses on risk, regulatory pathway logic, and evidence strategy—not technical detail overload. Many founders assume the best way to impress reviewers at the U.S. Food and Drug Administration is to provide as much technical detail as possible.