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Outset Medical, Inc. was cited for manufacturing the TabloCart with Prefiltration, a hemodialysis device component, without required premarket approval (PMA) or investigational device exemption (IDE), rendering it adulterated under federal law. The company also failed to submit a premarket notification (510(k)) to notify FDA of the device's intent for commercial distribution, violating device misbranding requirements. These violations were identified during an FDA inspection conducted from January 17 through February 10, 2023, at the company's San Jose, California facility.