FDA Considers Reclassifying Hemostatic Devices

Law360, New York (September 11, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration is considering reclassifying absorbable hemostatic devices, used to stanch bleeding during surgery, as medium rather than high risk, so that they can be approved without the need for clinical trials.

The FDA, which has been mulling the change since 2006, announced in Thursday's issue of the Federal Register that it was reopening its public comment period on the proposed change until Oct. 14.

The change would reclassify the devices as Class II, rather than Class III. While Class III devices...
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