FDA Lays Out Rules For Early Study Of Higher-Risk Devices

Law360, New York (October 2, 2013, 2:56 PM EDT) -- The U.S. Food and Drug Administration on Tuesday laid out new expectations for early clinical studies of higher-risk medical devices, describing a litany of conditions manufacturers must meet before such analyses are performed.

The 40-page guidance document covers investigational device exemptions that allow trials of unapproved products and applies only to so-called early feasibility studies, which tend to occur before device design has been finalized and involve a small group of 10 or fewer human subjects.

While many of the rules surrounding IDEs are contained in...
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