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Regulación de la FDA y aprobación de los dispositivos médicos: 1976-2020

Jonathan J Darrow1, Jerry Avorn1, Aaron S Kesselheim1

  • 1Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

JAMA
|August 3, 2021
PubMed
Resumen

La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) regula los dispositivos médicos para garantizar que los beneficios superen los riesgos. Durante 45 años, la regulación evolucionó con nuevas vías y un mayor financiamiento de la industria, pero persisten las preocupaciones por la seguridad del paciente.

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