FDAnews Device Daily Bulletin

Off-Label Promotion of Implant Results in Warning Letter

March 4, 2009
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Amedica allegedly promoted off-label use of its compact vertebral body replacement (VBR) device without seeking FDA marketing clearance or approval, according to a warning letter. The FDA considers Amedica’s Valeo-C VBR adulterated and misbranded because the company promoted uses that were not cleared in its 510(k) and had made changes that could significantly affect the safety and effectiveness of the device, the letter says.
Devices & Diagnostics Letter