Charlotte Lefkovich
Papers
1
Total Citations
4
H-Index
1
About
Charlotte Lefkovich is a legal scholar whose research sits at the intersection of health law, bioethics, and technology regulation. Her most-cited work, "The Use of Predicates in FDA Regulation of Medical Devices: A Case Study of Robotic Surgical Devices" (2018), critically examines the 510(k) clearance pathway—a streamlined process that allows new devices to enter the market without rigorous clinical trials if they are deemed "substantially equivalent" to an existing predicate. Through a detailed case study of robotic surgical systems, Lefkovich exposes how this reliance on predicates can allow flawed or recalled devices to remain on the market, raising profound questions about patient safety and regulatory accountability. While her citation count is modest, her work is foundational for scholars and policymakers grappling with the tension between innovation and oversight in medical technology. Her analysis has been cited in discussions of FDA reform and has informed broader critiques of regulatory capture. Lefkovich’s research is essential reading for anyone interested in how legal frameworks shape the safety and ethics of emerging medical devices.
Research Focus
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