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# Safety Reporting Investigator Responsibility Guidance
- URL: https://www.fdaweb.com/safety-reporting-investigator-responsibility-guidance/
- Published: 2021-09-29T12:00:00.000Z
- Updated: 2026-09-14T17:16:47.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5150243

FDA has published a draft guidance, *Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices*, to help clinical investigators comply with safety reporting requirements for IND or IDE studies. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigator-responsibilities-safety-reporting-investigational-drugs-and-devices?ref=fdaweb.com) has recommendations to help investigators identify **(1)** safety information for drugs that is considered an unanticipated problem involving risk to human subjects or others and therefore requires prompt reporting to institutional review boards, or **(2)** safety information for medical devices that meets the requirements for reporting unanticipated adverse device effects to sponsors and institutional review boards.

When the guidance is finalized, FDA says, it will supersede corresponding sections in a 2012 final guidance and a 2009 procedural final guidance.