A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and Potential Contributions.

Abstract

The postmarket surveillance system plays a vital role in managing residual risks and identifying safety signals in real-world clinical practice. The Food and Drug Administration (FDA) can order postmarket surveillance studies when safety concerns are raised. We conducted a thorough investigation of device characteristics, study statuses, and the outcomes of US postmarket surveillance studies. As of April 2017, we identified 338 orders, corresponding to 394 studies using the FDA database. Additio