Anulex Technologies, Inc. – FDA Warning Letter, Sep 22, 2010

The FDA issued a Warning Letter to Anulex Technologies, Inc. following an inspection from August 23 to September 22, 2010, concerning their clinical study "Randomized Study of Anular Repair with the Xclose? Tissue Repair System." The inspection revealed serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and Section 520(g) of the Federal Food, Drug, and Cosmetic Act. Key violations included: 1) Failure to submit an Investigational Device Exemption (IDE) application and obtain FDA approval before enrolling subjects, as the Xclose device for annulus fibrosus repair was deemed a significant risk device and a new investigational use requiring a Premarket Approval (PMA). 2) Promoting the investigational device (Xclose) for annulus fibrosus repair on its website and in press releases, representing it as safe and effective before FDA approval, which also rendered the device adulterated and misbranded. 3) Failure to obtain adequate signed investigator agreements, specifically lacking commitments from investigators to update financial disclosure information. Anulex's October 13, 2010, response was deemed inadequate, as it failed to acknowledge the investigational nature of the trial and incorrectly asserted no additional risks for anular repair. The FDA requires Anulex to provide written documentation of corrective actions, including projected completion dates, within fifteen working days to prevent further regulatory action.