Warning Letter to Outset Medical Cites Additional Observations

Outset Medical has announced that it received a warning letter from the FDA for promoting use of its Tablo hemodialysis system for continuous renal replacement therapy (CRRT) which is outside of current indications for the device, and for a lack of clearance of TabloCart, an accessory for the system.

The two observations in the July 5 warning letter are in follow-up to a Form 483 the company received after a Jan. 17-Feb. 10 inspection, Outset said. 

The company said it believes it has already addressed the promotion of CRRT through labeling and promotional changes already underway, adding that it intends to work collaboratively with the FDA to resolve the second observation, including potentially submitting a 510(k) on TabloCart.

The letter, the company said, “does not request the restriction of the manufacture, production or shipment of the Tablo System in the United States nor does it request the withdrawal of the Tablo System from the U.S. marketplace.”

 Read the Form 483 here. 

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