Company:Neurotone Systems Inc..
Product: RelaxPak, Neurotone III and Neurotone III D Cranial Electrotherapy Stimulator
Failure to establish, and maintain procedures for monitoring and control of parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75. [FDA-483 Item 4). Where the process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, must be documented. For example, your firm has not validated the software used in the Neurotone III D CES device. The Neurotone III D CES device has a microprocessor programmed with specific software to control the _____ and alternate the _____ Procedures for validating the device design to ensure that the device conforms to defined user needs and intended uses have not been provided, nor has the software validation been performed.
In addition, the Neurotone III D device is adulterated and misbranded because your firm failed to submit a 510(k) premarket notification for new indications for use and modifications to the device that could significantly affect the safety and effectiveness of the device, as required by Section 510(k) of the Act and Title 21, Code of Federal Regulations (CFR), Part 807.81. In contrast to the predicate device, the Neurotone III D device has two electrical outputs, is software controlled, and the _____ In addition, the device is intended for treatment of insomnia, depression, anxiety, improving sleep, and reducing fatigue. Consequently, the device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b).
Issuer: Center for Devices and Radiological Health (CDRH)