Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutional Review Boards - Final Guidance

Sajan Pandya, a Regulatory Affairs Specialist at Encore Medical Inc., supports the final guidance but argues it lacks a systematic framework for managing the investigator lifecycle to ensure sustained compliance. The commenter proposes that the FDA consider a companion guidance or appendix that addresses operational infrastructure, such as structured onboarding, ongoing training, and performance monitoring.