DC Circ. Defers To FDA In Stem Cell Device Marketing Row

Law360, Washington (March 22, 2013, 4:00 PM EDT) -- The D.C. Circuit on Friday backed the U.S. Food and Drug Administration’s denial of expedited marketing approval for two Cytori Therapeutics Inc. devices that harvest stem cells from fat tissue, saying the court is ill-equipped to second guess the agency’s scientific decisions.

The three-judge panel ruled unanimously that the FDA had reasonably determined and explained that Cytori’s Celution 700/LAB and StemSource 900/MB devices aren’t eligible for 510(k) marketing approval, which is reserved for devices similar to products already on the market.

Cytori's devices harvest stem cells...
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