Assessing the Safety and Effectiveness of Devices After US Food and Drug Administration Approval

Abstract

Postapproval studies have the potential to provide additional information to better understand medical device performance. However, small sample sizes, delays in reaching protocol agreement, and lack of availability of findings may hinder their ability to be clinically useful. Owing to the lack of information on the effect of studies, it is unclear whether the program achieves its aims. Improved completion and accessibility of PASs could help answer important questions of safety and effectiveness about medical devices. To better understand the real-world performance of these products, they should be better integrated with other sources of information about device performance.