Outset Medical, Inc. – FDA Warning Letter, Feb 10, 2023

On July 5, 2023, the FDA issued a Warning Letter to Outset Medical, Inc., following an inspection from January 17 to February 10, 2023, at their San Jose, CA facility. The inspection determined that the firm manufactures the Tablo Hemodialysis System and TabloCart with Prefiltration, both classified as medical devices.

The letter identified two unapproved device violations. First, the TabloCart with Prefiltration is adulterated under section 501(f)(1)(B) and misbranded under section 502(o) of the Act because the firm lacks an approved PMA or IDE, and failed to submit a 510(k) premarket notification. Marketing materials indicate its use for "prefiltration" with the Tablo Hemodialysis System, aligning with the definition of a Class II water purification system for hemodialysis (21 CFR 876.5665).

Second, the Tablo Hemodialysis System is adulterated and misbranded for being promoted for continuous renal replacement therapy (CRRT) treatment, which is outside its cleared indications for use (K223248). The FDA noted that CRRT is distinct from the cleared indications and represents a significant modification requiring a new 510(k) premarket notification under 21 CFR 807.81(a)(3)(