FDA WARNING_LETTER - Nikkiso Medical America, Inc - July 06, 2021

The FDA issued a Warning Letter to Nikkiso regarding the marketing of its DBB-06 device in the United States without proper marketing clearance or approval. A February 5, 2021 review of Nikkiso’s marketing materials revealed two primary violations. First, the DBB-06 is 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 described and marketed. Second, the device is misbranded under section 502(o) of the Act and 21 CFR 807.81(a)(3) because Nikkiso introduced a significant change—a physiological closed loop controller (PCLC) system—without submitting a new premarket notification (510(k)). This PCLC functionality, which allows for automatic adjustments to dialysis therapy, was not described in the original 510(k) clearances (K091978, K152938) and could significantly affect device safety and effectiveness, introducing new risks. The FDA had previously communicated these concerns to Nikkiso, including an "It has come to our attention" letter in August 2019. Nikkiso is required to immediately cease activities leading to misbranding or adulteration, such as distributing the DBB-06 with the PCLC function. The firm must provide a written response within fifteen business days detailing corrective actions, prevention plans, and a timetable for completion, or face potential regulatory actions like seizure, injunction, or civil money penalties.