Outset Medical, Inc.

CLOSEOUT LETTER Outset Medical, Inc. MARCS-CMS 656485 — February 13, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Leslie Trigg Recipient Title Chair and CEO Outset Medical, Inc. 3052 Orchard Drive San Jose , CA 95134-2011 United States Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear Ms. Trigg: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 656485, dated 7/5/2023. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ for RDML Sean M. Boyd, MPH, USPHS Director Office of Regulatory Programs Office of Product Evaluation and Quality Center for Devices and Radiological Health Content current as of: 02/19/2025 Regulated Product(s) Medical Devices