FDA WARNING_LETTER - Myotronics-Noromed Inc. - May 12, 2011

This FDA Warning Letter, issued by the Office of Compliance, Center for Devices and Radiological Health, addresses Myotronics-Noromed, Inc. following an inspection of their Kent, Washington facility from April 25 to May 12, 2011. The letter identifies significant violations related to the marketing and promotion of their K7 Evaluation System, J5 Myo-monitor, and BNS-40 biofeedback and goniometer devices. FDA determined that the firm is promoting these devices for new intended uses, such as treating various types of headaches (migraine, sinus, cluster), through print advertisements, brochures, and websites, without obtaining the required marketing clearance or approval. Specifically, the K7 Evaluation System, J5 Myo-monitor, and BNS-40 were cleared for explicitly identified uses, but the firm disseminated marketing materials with uncleared medical claims. Consequently, these devices are deemed adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. § 351(f)(1)(B)) due to the lack of an approved Premarket Approval (PMA) application or Investigational Device Exemption (IDE) for the new uses. Furthermore, the devices are misbranded under section 502(o) of the Act (21 U.S.C. § 352(o)) because the firm failed to notify the agency of its intent to introduce the devices into commercial distribution for these new uses, as required by section 510(k) (21 U.S.C. § 360(k)). Myotronics-Noromed, Inc. is required to take prompt corrective action and notify FDA in writing within fifteen working days, detailing steps taken, prevention plans, and a timetable for implementation. Failure to correct these violations may lead to regulatory actions including seizure, injunction, civil money penalties, and impact on federal contracts. The letter also emphasizes that these issues may indicate broader problems within the firm's manufacturing and quality assurance systems.