When planning a clinical research study intended to support an FDA submission , sponsors often encounter terms such as multi-site, multi-investigator , and single-site, multiple-location . While these models may appear operationally similar, they differ in oversight structure, execution, and how evidence is evaluated by the FDA—particularly for cuffless blood pressure devices . Understanding these distinctions is essential for aligning trial design with FDA expectations and w

When developing a new medical device or wearable technology, navigating the FDA regulatory pathway can be complex and resource-intensive....

For medical device innovators, the leap from prototype to regulatory submission is filled with risk. Even a well-engineered product can...