Cytori Protests FDA's Cold Shoulder Toward Its Devices

Law360, Washington (September 21, 2012, 3:39 PM EDT) -- Cytori Therapeutics Inc. told a D.C. Circuit panel Friday the U.S. Food and Drug Administration had erred when it denied marketing approval for two Cytori medical devices and failed to consider alternative options that would have assuaged its concerns.

Cytori claims the FDA refused to grant 510(k) approval for two devices — Celution 700/LAB and StemSource 900/MB — that harvest stem cells from fat tissue over off-label marketing concerns, which it never consulted the company about.

Cytori's counsel Andrew S. Ittleman said labeling provisions, doctor notifications...
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