Comment from Sajan Sanjay Pandya
AnonymousSupportBusiness
Summary: 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.
This comment addresses the final guidance "Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices" (Docket No. FDA-2021-D-0368, December 2025). Drawing on operational experience managing investigator oversight across eight active clinical sites in an IDE pivotal trial (PERFORM, IDE G220115), this comment identifies a structural gap between the guidance's safety reporting recommendations and the operational infrastructure sponsors need to ensure sustained investigator compliance. The Integrated Prospective Regulatory Governance (IPRG) framework's Investigator Lifecycle Management pillar is presented as a model for addressing this gap. Detailed comments are in the attached document.