FDA WARNING_LETTER - Red Oak Instruments, LLC - July 26, 2024

The FDA issued a Warning Letter to Red Oak Instruments, LLC (Red Oak, ROI) following an inspection from July 15-26, 2024, identifying significant violations for their AC Powered Dynamometer RU-Fit (Model SR-3053) medical device.

The RU-Fit (Model SR-3053) is deemed adulterated and misbranded. It is adulterated because Red Oak lacks an approved premarket approval (PMA) or investigational device exemption (IDE) for the device as marketed. It is misbranded because Red Oak introduced the device with major changes to its intended use without submitting a new premarket notification (510(k)). The device, previously cleared for hand grip/pinch strength assessment, is now marketed for screening mild traumatic brain injury (mTBI) and assessing reaction/cognitive function, which constitutes a major change in intended use requiring new clearance or approval.

Additionally, Red Oak failed to adequately develop, maintain, and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17). Deficiencies include lack of definitions for reportable events, inadequate instructions for evaluating events and conducting investigations, incomplete procedures for timely transmission of reports (e.g., FDA 3500A form, electronic submission), and insufficient documentation and record-keeping requirements. Red Oak also lacks an active Electronic Submissions Gateway (ESG) production account for eMDR.