Draft rules on investigational device exemption trials unveiled

11/14/2011 | MassDevice.com (Boston)

The FDA has unveiled two draft guidance documents for products seeking investigational device exemption. The first details new feasibility research approaches to guide a product's final design better and enable studies to start sooner, while the second describes the process for approving clinical trials. The agency also launched an amended standard operating procedure for obtaining new data from devices undergoing premarket evaluation.

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MassDevice.com (Boston)

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