MedTech Founders & Regulatory Leaders - OUS Pivotal Trials 50% US Myth

There is no 50% US patient rule. Not for 510(k). Not for De Novo. Not for PMA. Every scoping call I run, the same question arrives within thirty minutes: "If we run our pivotal entirely in Latin America, don't we still need 50% of patients enrolled in the US?" The question is reasonable. The premise is wrong. I have had this conversation with more founders than I can count. Someone on their advisory board heard it from a former FDA reviewer. Or their regulatory consultant mentioned it in passing. Or they read it in a deck from a competing CRO that benefits from US-only enrollment. And now it is gospel. The controlling regulation is 21 CFR 812.28. It establishes the conditions under which FDA will accept data from investigational device studies conducted outside the United States. It says nothing about requiring a minimum percentage of US patients. The standard is whether the study was conducted in accordance with GCP, whether the data is applicable to the US population, and whether FDA had sufficient oversight. What this means in practice is that a well-designed pivotal study run entirely OUS, with proper Pre-Sub alignment and GCP compliance, can support a US marketing submission. I have helped sponsors do exactly this across Latin America. The founders who understand this close stronger fundraising rounds because they design clinical programs that cost less and move faster. The founders who default to conservative US-only convention out of an assumption that was never a regulation lose a year and several million dollars before they realize what happened. If you are a MedTech founder, regulatory leader, or investor who has a strong opinion on OUS clinical strategy, I want to hear from you on Global Trial Accelerators™. We are building the definitive podcast for clinical research decision-makers, and this is one of the topics that generates the most debate.