What is the average time for a 501(k) application with clinicals under the regulatory pathway?

The average time for a 501(k) application that includes clinical data typically falls within the range of 6 to 12 months. This timeframe reflects the standard regulatory process established by the U.S. Food and Drug Administration (FDA) for devices that require additional clinical evidence to demonstrate safety and effectiveness.

The 501(k) process is designed for devices that are substantially equivalent to existing legally marketed devices, which helps expedite their approval compared to more complex premarket approval applications. While factors such as the complexity of the device, the quality of the submitted data, and the need for regulatory discussion can influence the timeframe, 6 to 12 months is a realistic expectation for many applications in this category when clinical studies are involved.

In contrast, other options reflect either shorter or considerably longer timelines that do not appropriately align with the established norms for 501(k) applications with clinical data. Shorter timelines may not accommodate the thorough review process needed for clinical studies, while longer timelines suggest more complex applications generally associated with premarket approvals rather than 501(k) submissions.