Una revisión general de la legislación de dispositivos médicos de la Administración de Alimentos y Medicamentos (FDA) y su interacción con las prácticas médicas actuales

Resumen

Since the emergence of medical devices, legislation has been developed to allow the Federal Drug Administration (FDA) to oversee their development, marketing, and usage. This paper discusses the history of the FDA's involvement in medical devices, current approval processes, and several case examples. Additionally, it discusses both short- and long-term effects with unexpected consequences to U.S. health care delivery.