Former medical device manager pleads guilty to misbranding
Device Regulation Alert: Safety, Compliance and Reimbursement News, December 1, 2008
Darnell Martin, 35, of Chicago, pleaded guilty to one count of making a false statement and one count of felony misbranding, according to a Department of Justice (DOJ) press release.
According to the DOJ, Martin worked for a medical device company that manufactured and sold medical devices designed to promote bone growth. The FDA approved the device only for Humanitarian Device Exemption, meaning medical facilities that have established a local institutional review board (IRB) can use the device. The IRB must approve the device before its use.
Martin allegedly falsified IRB approval, leading a Wisconsin medical facility to use the device even though its IRB had not approved it. Martin also allegedly marketed the device for an off-label use.
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