About a year after the company’s last distribution hold wrapped up, Outset Medical is once again pausing shipments of a component of its Tablo hemodialysis systems.
This time around, the hold is related to certain versions of the TabloCart, an accessory to the larger system that launched last year that places the dialysis machine on 360-degree rotating wheels. The TabloCarts currently on hold include an additional, optional feature that provides prefiltration for the water used in dialysate mixtures.
Outset CEO Leslie Trigg announced the pause in distribution alongside the company’s second-quarter results earlier this month.
The shipping pause comes after the FDA singled out the TabloCarts in a recent warning letter. Disclosed by Outset in early July, the letter followed an inspection of the company’s facilities at the start of the year and, in part, described the FDA’s belief that the prefiltration feature requires regulatory clearance.
“Although we had evaluated TabloCart with Prefiltration prior to marketing and distributing the product and concluded that no marketing authorization was necessary, we’ve made the decision to submit a 510(k) and pause its distribution until clearance has been granted,” Trigg said in a call with investors last week.
The company has been “in dialogue with FDA” throughout the warning letter process, Trigg said, and plans to submit the 510(k) clearance application “by the end of this month.”
The chief executive also discussed a second concern raised in the warning letter. There, the FDA took issue with Outset’s promotion of continuous renal replacement therapy in company materials, despite the fact that the Tablo system has not been cleared to provide the slowed-down version of dialysis.
In its initial disclosure about receiving the warning letter, Outset reported that it had already tweaked its labeling and promotional materials to address the issue, and Trigg added in this month’s investor call that the adjustments are believed to have settled the FDA’s concerns.
“I want to emphasize that neither of these two additional observations pertain to safety, efficacy or quality, and, importantly, the letter did not place any restrictions on the Tablo system itself,” Trigg said.
“While we were surprised by the warning letter, our intent is always to innovate in lockstep with an adherence to the highest quality and regulatory standards, and that is exactly how we’ve approached our response to the warning letter,” she concluded. “We believe the actions we have taken are the right steps towards resolving these observations and further strengthening our competitive position.”
The warning letter came several months after the FDA’s initial follow-up report from the January inspection, with a Form 483 outlining four separate issues that were subsequently resolved by Outset.
The current shipment hold, meanwhile, begins almost exactly a year after Outset’s previous hold was lifted. In that case, the company held off on shipping Tablo systems for at-home use for about six weeks, as it awaited an expansion to the existing 510(k) clearance for new features added to the system since the initial 2020 green light.