FDA proposes guidelines that clarify benefit-risk determinations for medical devices

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA proposes guidelines that clarify benefit-risk determinations for medical devices

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FDA proposes guidelines that clarify benefit-risk determinations for medical devices

08/15/2011 10:00 AM EDT

For the first time, the U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.

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