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Regulatory Focus

‘Our goal is to capture the vision of global harmonization in regulating medical devices.’ This is the ambitious aim of the US Food and Drug Administration (FDA) as it continues its piloting of a Global Harmonization Task Force (GHTF) initiative to evaluate the utility of an internationally harmonized format and content for premarket device submissions1.

In this issue of RAJ Devices, we publish the first of two articles on the initiative, known as STED (Summary...

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