U.S. FDA Medical Device Predicate Selection for 510(k) Submissions

Identifying the right predicate device to streamline the 510(k) submission process

Navigating the FDA’s 510(k) premarket notification pathway is essential for medical device manufacturers seeking market approval. A crucial component of this process is selecting an appropriate predicate device. While this step can be straightforward in many cases, some submissions require additional time, research and strategic planning to identify the right predicate or reference device.

Predicate selection

This whitepaper explores the details of predicate selection, offering expert insights and actionable strategies to streamline the 510(k) submission process and increase the chances of success.