FDA 483 - Steve E. Canfield, M.D. - November 27, 2024

An FDA inspection of Steven E. Canfield, M.D., a clinical investigator in Houston, TX, revealed two significant observations. The firm failed to provide timely financial disclosure updates to the sponsor and did not adequately or timely evaluate and report Adverse Device Effects for study subjects. These findings indicate non-compliance with regulatory requirements for clinical investigations.