FDA 483 - Nalu Medical, Inc. - April 28, 2021

An FDA inspection of Nalu Medical, Inc. in Carlsbad, CA, a manufacturer of the Nalu Neurostimulation System, revealed two significant observations. The firm failed to adequately validate device software, specifically a compiler tool, despite its risk classification. Additionally, procedures for corrective and preventive actions were found to be inadequately established and implemented, with multiple open and delayed CAPA and complaint investigations.