Certain medical devices with FDA priority review have higher recall rates

High-risk, or class 3, medical devices that underwent FDA priority review had higher recall rates and less time on the market before serious recalls vs. high-risk devices that received standard review, data published in JAMA Internal Medicine showed.“The FDA requires that high-risk (class 3) medical devices undergo premarket approval review, the most stringent path through which devices enter the market,” Caroling Ong, MD, MHS, first-year cardiology fellow in the division of cardiology at NYU Grossman School of Medicine, and colleagues wrote. “Since 1994, in an effort toRead More

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