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Post-market studies of high-risk medical devices are slow to yield results
Modern Healthcare

Medical-device makers are slow to complete studies on the safety and effectiveness of medical devices such as pacemakers, heart valves and stents after the products enter the market, according to new research. Some are never completed at all.

Researchers reviewed post-market clinical studies for more than two dozen high-risk medical devices introduced in 2010 and 2011. The majority weren’t finished. That included 33 marketplace studies that the Food and Drug Administration required when it approved the device.

The results, published Tuesday in JAMA, add to other studies that raise concerns about the quality of clinical research required by regulators for high-risk devices. The concerns come as Congress debates new legislation known as the 21st Century Cures Act, which has been criticized for relaxing safety standards for medical devices by allowing less rigorous evaluation before approval.