What is it about?
This article provides an overview of the regulation of medical devices and drugs in the European Union and United Sates.
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Why is it important?
It is important for all stakeholders involved in bringing a medical device or drugs to market to have an understanding of the regulatory requirements involved in this process. This article demonstrates that the regulation of these products is an extremely complex process.
Perspectives
I know from first hand experience that not understanding or knowing the medical device and drug regulatory frameworks can significantly delay manufacturers attempting to bring new devices and drugs to the international market. Such delays can result in patients not receiving timely benefits from technological breakthroughs. I hope you find that this article explains in simple and clear language these regulations.
Fiona Masterson
National University of Ireland
Read the Original
This page is a summary of: Overview of the Regulation of Medical Devices and Drugs in the European Union and the United States, Therapeutic Innovation & Regulatory Science, September 2013, SAGE Publications,
DOI: 10.1177/2168479013500969.
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