Forget perfect scores! The FDA's real concern often boils down to one thing: can a stressed-out user *actually* open the packaging without creating a danger? 🤯 When preventing medication errors (DEMIPA) is the primary focus, and efficacy/safety aren't major issues, resubmission approval rates jump to an incredible 80-90 percent! That’s the powerful, often overlooked, regulatory pathway being discussed. A fascinating look at how usability under pressure dictates success in the approval game. #FDAApproval #MedTech #DrugSafety #RegulatoryAffairs #MedicalDevice - @dansfera