Nonconcurrent Control Use in FDA Approval of High-Risk Medical Devices.

Abstract

The US Food and Drug Administration (FDA) may consider historical controls, objective performance criteria, or performance goals as alternatives to concurrent control groups in clinical studies evaluating safety and/or effectiveness of high-risk medical devices. However, nonconcurrent control use has limitations. To examine frequency, justification, and clinically relevant details for use of nonconcurrent controls in pivotal studies supporting FDA approval of high-risk medical devices. Cross-sec