FDA WARNING_LETTER - Dynavision International LLC - April 26, 2017

An FDA inspection of Dynavision International, LLC in West Chester, Ohio, from April 18-26, 2017, revealed significant violations concerning the Dynavision D2 device, an attention task performance recorder. The device was found to be adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE) for the device as currently marketed. It was also misbranded under section 502(o) for introducing the device with major changes to its intended use without submitting a new 510(k) premarket notification, as required by 21 CFR § 807.81(a)(3)(ii). The original clearance was for "measurement of reaction time," but the firm promotes it for uncleared therapeutic, rehabilitation, and diagnostic claims related to conditions like stroke, TBI, Parkinson's, and concussion management. Additionally, the inspection identified several Quality System (CGMP) regulation violations under 21 CFR Part 820, including failure to establish purchasing control procedures (21 CFR 820.50), failure to establish design control procedures (21 CFR 820.30(a)(1)), failure to maintain a Design History File (21 CFR 820.30(j)), failure to perform a risk analysis (21 CFR 820.30), and failure to establish adequate procedures for design changes (21 CFR 820.30(i)). The firm's May 13, 2017, response to the FDA 483 was deemed inadequate for purchasing controls and could not be assessed for design controls. Dynavision International, LLC is required to immediately cease activities causing misbranding or adulteration and provide a written response within fifteen working days detailing corrective actions, prevention plans, and implementation timelines to avoid potential regulatory actions such as seizure, injunction, or civil money penalties.