FDA questions Outset Medical’s marketing of Tablo dialysis products
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Outset Medical Inc. reported in a recent 8-K filing that it had received a warning letter from the FDA expressing concerns about the company’s marketing of its Tablo dialysis machine and other products.
In its Securities and Exchange Commission 8-K filing released on July 7, Outset said the FDA warned the company about information on the company website that promoted continuous renal replacement therapy, which the FDA said was “a modality outside of the current indications for the Tablo hemodialysis system,” according to the Outset filing. Outset wrote, “The company believes this concern has been effectively addressed through labeling and promotional changes already underway.”
In the letter, the FDA also warned Outset about promoting its TabloCart with prefiltration to be used in conjunction with the Tablo hemodialysis system. The FDA said the cart “requires prior 510(k) clearance for marketing authorization,” according to the Outset filing. The TabloCart, a nonmedical accessory, was launched in the third quarter of 2022 and “sales to date have not been material to the company’s financial results,” the company wrote in the filing.
“The company intends to work collaboratively with the FDA to resolve this observation, including potentially submitting a 510(k) on TabloCart,” Outset wrote in the filing.
Outset said the letter from the FDA does not request the company to halt production or shipment of the Tablo dialysis machines in the United States.
“The company intends to fully cooperate with the FDA, including by responding within 15 business days, to expeditiously and completely resolve the warning letter,” the company told Healio.com. “The company cannot, however, give any assurances that the FDA will be satisfied with the company’s actions taken in response to the matters raised in the warning letter. The company also cannot give any assurances as to the timing of the resolution of such matters,” Outset said. “We take these matters very seriously and we intend to fully cooperate with the FDA to resolve these two items.”
References:
- United States Securities and Exchange Commission, Form 8-K.
- https://www.sec.gov/ix?doc=/Archives/edgar/data/0001484612/000119312523183869/d511727d8k.htm. Published July 7, 2023. Accessed July 11, 2023.
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