Medical Device Regulation – Who Does the FDA Serve?

2026/01/01 by Osman Moneer, Vinay Rathi
Economics, Econometrics and Finance · Medicine · #Biomedical Ethics and Regulation #Health Systems, Economic Evaluations, Quality of Life #Pharmaceutical Economics and Policy

paper · pdf · doi:10.1017/jme.2025.10217

openalex publication_date 2026/01/01 · openalex created_date 2026/03/26 · openalex updated_date 2026/07/15

Abstract

Political pressures and institutional constraints have shaped a reactionary regulatory system that unduly preferences industry interests over public health. Breaking the reactive cycles that have long shaped device regulation will involve more than standard technical or incremental reforms. Congress would instead need to revisit more foundational values of device regulation to better align policy with the interests of patients and public health.

Citations

• A Theory of Quantum Gravity from First Principles

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