ArjoHuntleigh Inc. – FDA Warning Letter, Aug 2, 2013

The FDA inspected ArjoHuntleigh, Inc. from July 24 to August 2, 2013, regarding their RotoRest Delta, RotoProne, and TriaDyne Therapy Systems. The FDA determined these devices are adulterated under section 501(f)(1)(B) of the Act because the firm lacks approved premarket approval (PMA) or investigational device exemption (IDE) applications for their marketed uses. The devices are also misbranded under section 502(o) for being introduced into interstate commerce for uses different from legally marketed devices (21 CFR 890.5225) without submitting a premarket notification (510(k)), as required by section 510(k) and 21 C.F.R. 807.81(a)(3)(ii). The firm markets these systems for preventing and treating pulmonary complications like ARDS and VAP, which differ from the intended uses of exempt devices. Furthermore, the devices are misbranded under section 502(t)(2) due to the firm's failure to furnish required Medical Device Reporting (MDR) information under section 519 and 21 CFR Part 803. Specifically, the firm failed to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17, with deficiencies noted in timely report transmission and documentation. ArjoHuntleigh must promptly correct these violations and respond within fifteen business days with specific steps, preventative plans, and documentation, or face regulatory actions including seizure, injunction, and civil money penalties. The letter emphasizes that these issues may indicate broader problems in the firm's quality management systems.