FDA Warning Letter to Outset Medical over Tablo System promotion and TabloCart clearance

Outset Medical, Inc.

FDA Warning Letter dated July 5, 2023 received July 6, 2023, citing two observations: promotional material for CRRT outside Tablo indications, and TabloCart needing 510(k) clearance.
Company believes CRRT issue addressed via labeling/promotional changes; TabloCart launched Q3 2022 with immaterial sales to date.
Warning Letter does not restrict manufacture, shipment, or require withdrawal of Tablo System from U.S. market.
Company to respond within 15 business days; will cooperate with FDA and may submit 510(k) for TabloCart.

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