FDA Launches Innovation Pathway 2.0

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The Food and Drug Administration’s Center for Devices and Radiological Health on Monday launched Innovation Pathway 2.0 that offers new and modified tools and methods to deepen collaboration between the FDA and innovators.

The pathway, which launched its first version in 2011, aims to get new medical tools, devices and innovations into the hands of medical experts prior to pre-market submission, with the goal of making the regulatory process more efficient and timely.

The Pathway serves as a living laboratory to test new tools and methods for breakthrough devices that we may also apply to other technologies to enhance all device pre-market programs.

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