FDA 483 - Exer Labs, Inc. - October 24, 2024

An FDA inspection of Exer Labs, Inc., a medical device manufacturer in Denver, CO, revealed 10 significant observations regarding their quality system. The firm lacked established and documented procedures across numerous critical areas, including design control, corrective and preventive actions, complaint handling, medical device reporting, and management review. These findings indicate a fundamental absence of a robust quality management system for their Exer Scan Software as a Medical Device (SaMD) product.