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Home » Device Trial Sponsors Cited in Two Warning Letters
Device Trial Sponsors Cited in Two Warning Letters
April 20, 2007
A hearing implant company sponsoring a device study failed to provide clinical investigators with information on hearing loss among participants, and the sponsor of another device clinical trial provided "misleading" assurance to participants that the investigational device had been judged safe by the FDA, according to two separate FDA warning letters posted recently to the agency's website.