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# Suggestions for Investigator Safety Reporting Guidance
- URL: https://www.fdaweb.com/suggestions-for-investigator-safety-reporting-guidance/
- Published: 2021-11-30T12:00:00.000Z
- Updated: 2026-09-14T17:24:00.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5150668

AdvaMed says it supports FDA efforts to provide up-to-date guidance to help clinical investigators comply with IDE studies. In an 11/19 [comment](https://downloads.regulations.gov/FDA-2021-D-0368-0005/attachment%5F1.pdf?ref=fdaweb.com) on an agency draft guidance, *Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices*, AdvaMed makes both general and specific comments.

It says that while sponsors play a key role in ensuring that investigators comply with relevant IND and IDE regulations, it would be helpful to expand the guidance title to include both investigators and industry. “This will facilitate compliance with the recommendations made in the guidance,” AdvaMed says.

The association also asks FDA to clarify if real-world evidence investigations are within the guidance’s scope.

In its 11/29 [comment](https://downloads.regulations.gov/FDA-2021-D-0368-0006/attachment%5F1.pdf?ref=fdaweb.com), AstraZeneca provides line-by-line specific comments.