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February 14, 2012New England Journal of Medicine273 citations

Regulation of Medical Devices in the United States and European Union

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DKDaniel B. KramerSXShuai XuAKAaron S. Kesselheim

Key Points

  • The aim is to compare the regulatory frameworks for medical devices in the United States and the European Union.
  • Analyzed regulatory requirements for high-risk medical devices in the US and EU.
  • Examined the impact of these regulations on clinical testing and patient access.
  • The US requires more rigorous clinical testing for high-risk devices than the EU.
  • This rigorous testing delays patient access to new devices but may enhance overall device safety.

Abstract

As compared with Europe, the United States generally requires more rigorous clinical testing of high-risk devices, which delays patients' access to new devices but may provide better assurance of device safety.

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Cite This Study

Kramer et al. (2012) studied this question.

synapsesocial.com/papers/69d575fa493d9d40f8442722https://doi.org/10.1056/nejmhle1113918
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