What is a "foreign clinical study"?

A "foreign clinical study" is defined as a research study conducted outside the USA with the specific purpose of gathering safety and efficacy data for medical devices. This definition is pivotal in regulatory contexts, particularly for submissions to the FDA, as data from these studies can support claims made in premarket submissions for devices intended for marketing in the United States.

When medical device manufacturers conduct studies in countries outside of the U.S., the data generated can be utilized in applications for regulatory approval, provided that the study adheres to good clinical practice and the methodologies align with regulatory expectations. This route is often taken when there are patient populations, conditions, or specific capabilities that are better represented or available in other nations compared to the U.S.

The other options do not encapsulate the foundational concept of a foreign clinical study as accurately. For instance, a study conducted in multiple countries does not necessarily highlight the sole purpose of gathering efficacy and safety data, while a focus on foreign regulations or evaluating commercial viability does not embody the clinical research aspect central to the definition of a foreign clinical study.