Nonconcurrent Control Use in FDA Approval of High-Risk Medical Devices.
PMID: 40261654 ·
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초록
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
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