ZYTO Technologies was issued a warning letter from the FDA for the reason of “the ZYTO Hand Cradle GSR and associated proprietary software 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).” More specifically, “You have added disease claims back to your software library, Your firm continues to market the ZYTO Hand Cradle GSR to predict biological responses to a range of virtual stimuli, as discussed in your 2015 Warning Letter, You have not conducted design verification and validation testing per the requirements of 21 CFR 820.30(f) and 820.30(g), and your SOP-00302 Design Verification and Validation, rev D, eff 12/14/2020, for the ZYTO Hand Cradle GSR and associated proprietary software, or the device library development processes used in house and by customers, You failed to verify or validate the ZYTO Hand Cradle GSR and associated proprietary software.”
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