Medical Devices — Balancing Regulation and Innovation

Puntos clave

Los puntos clave no están disponibles para este artículo en este momento.

Resumen

The FDA approval system cannot assure the safety and effectiveness of increasingly complex medical devices. The Institute of Medicine has recommended eliminating a process that permits approval of a device based on its “substantial equivalence” to an existing device.

Me gusta

Guardar

Cite This Study

Curfman et al. (Wed,) studied this question.

synapsesocial.com/papers/6a15b1995347fbb173a0276b https://doi.org/https://doi.org/10.1056/nejmp1109094

Me gusta

Guardar

Also Consider

Synapse has enriched one closely related paper. Consider it for comparative context:

1Medical Devices and Health — Creating a New Regulatory Framework for Moderate-Risk Devices2011 · 66 citations

Also Consider

Synapse has enriched one closely related paper. Consider it for comparative context:

1Medical Devices and Health — Creating a New Regulatory Framework for Moderate-Risk Devices2011 · 66 citations