Medical Device Regulation - Who Does the FDA Serve?
PMID: 41879133 ·
O, s, m, a, n, , M, o, n, e, e, r, ;, , V, i, n, a, y, , R, a, t, h, i
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ZeitschriftThe Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
Jahr
PMID41879133
Zusammenfassung
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.
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