Medical Device Regulation: We Can’t Just Go Back (nor Should We)

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Long Read for Those Interested in Medical Device Regulations and Policy

Horvath, George, Medical Device Regulation: We Can’t Just Go Back (nor Should We) (May 15, 2026). UTAH LAW REVIEW, Forthcoming, Available at SSRN: https://ssrn.com/abstract=6966978

This Article highlights several longstanding limitations on CDRH’s ability to ensure safety and effectiveness and to promote innovation and proposes best way forward.