For MedTech startups, moving fast is essential, but moving forward without a clear regulatory roadmap is a recipe for disaster. Too many companies dive headfirst into product development, only to realize right before their planned launch that they lack the required testing and documentation for regulatory approval. The result is a forced retreat back to the development stage, redesigning the device and wasting immense amounts of time and investor capital. Performing a compreh

Executive Summary The United States Food and Drug Administration (FDA) has fundamentally transformed the medical device regulatory landscape by transitioning from traditional paper and eCopy submissions to the electronic Submission Template And Resource (eSTAR) program. As of recent updates, including the major release on June 1, 2026, understanding the intricacies of the eSTAR system is no longer optional - it is a critical competency for MedTech regulatory affairs teams.