Outset Medical, Inc. – FDA 483, Feb 10, 2023

Outset Medical, Inc. in San Jose, CA, received a Form FDA 483 with four observations related to their Tablo Hemodialysis System. The inspection revealed significant issues including failure to submit a Medical Device Report for a patient death, incomplete software validation, inadequate procedures for nonconforming product disposition, and undocumented corrective and preventive actions. These findings indicate deficiencies in their quality system and post-market surveillance.