A new JAMA article co-authored by BAHM member Pinar Karaca-Mandic at the University of Minnesota – Carlson School of Management, outlines associations between 510(k) medical device regulatory characteristics and their recall probability: https://jamanetwork.com/journals/jama/article-abstract/2800188
Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
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