Dive Brief:
- Outset Medical received a warning letter from the Food and Drug Administration related to its Tablo Hemodialysis System, the company disclosed in a Friday financial filing.
- The warning letter said that some materials on Outset Medical’s website promoted continuous renal replacement therapy, which is outside of the current indications for the Tablo system. The FDA also said that Outset needs 510(k) clearance to sell TabloCart with Prefiltration, a device accessory designed to filter carbon and sediment out of water.
- The FDA has not yet published a copy of the warning letter on its website. The FDA warning letter does not restrict the dialysis device maker from manufacturing or shipping its Tablo System, Outset said.
Dive Insight:
San Jose, Calif.-based Outset makes portable dialysis systems designed to be used in hospitals, dialysis centers and at home.
The warning letter follows a Feb. 10 inspection of Outset’s San Jose facility by the FDA. Outset received a Form 483 that month with four observations that the company has since addressed. The warning letter, dated July 5, raised two additional concerns.
Outset said it believes it has “effectively addressed” the first concern, related to promoting its device for continuous renal replacement therapy.
Stifel analyst Rick Wise wrote in a research note that the FDA’s concerns were not related to company assertions, but rather were directed at customer comments published on its website. Outset said that it scrubbed those references from its website, he added.
The second concern, related to Outset’s TabloCart accessory, is more complex, Wise wrote. Outset said it intends to work with the FDA to resolve the observation, including potentially submitting the device for 510(k) clearance.
The FDA has not yet placed any restrictions on TabloCart with Prefiltration being sold, Wise wrote. The company said that sales of the accessory — which launched in the third quarter of 2022 — have been immaterial, suggesting that a potential pause in sales associated with a regulatory submission “would have an immaterial impact to sales as well,” he said.
Analysts said that Outset should be able to resolve the concerns raised by the FDA.
“While the Warning Letter is not an ideal outcome for any company, our conversations suggest the observations are addressable and should be manageable by [Outset],” RBC Capital Markets analyst Shagun Singh wrote in a research note.
Outset hired a chief regulatory officer in late 2022 and is working with an expanded regulatory team to improve its compliance program, which could mitigate future regulatory issues, Wise added.