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Sales rep admits misbranding medical devices
December 5, 2008
By: Editor
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A former device sales representative, Darnell Martin, has pleaded guilty to charges of misbranding medical devices made by a Massachusetts company, referred to in court documents as “XYZ Corp.” Martin was charged with falsifying institutional review board (IRB) approval of a humanitarian device exemption (HDE) implant to promote bone growth in certain long bone nonunions for a medical facility in Wisconsin and forging the signature of the IRB chairman, the court document said. He also promoted the sale and combined use of other HDEs and distributed “mixing instructions” for the unapproved use. SOURCE: FDA NEWS
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