FDA Unveils New Analysis Rules For Medical Devices

Law360, New York (April 26, 2010, 6:38 PM EDT) -- The U.S. Food and Drug Administration on Monday announced changes in the way expert panels will analyze whether a medical device should be approved for the general market, hoping a new approach will improve discussions and foster better flow of information.

Panel members conducting premarket public hearings will be asked to vote on the safety and effectiveness of a device and its risk-benefit ratio, rather than the approvability of premarket applications and conditions of approval, the FDA said in a statement.

The changes will allow panelists...
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