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Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices Draft Guidance for Industry September 2021

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research

This guidance is intended to help clinical investigators comply with the following safety reporting requirements:

  • · Investigational new drug application (IND) studies under § 312.64(b) (21 CFR 312.64(b)
  •    Investigational device exemption (IDE) studies under § 812.150 (21 CFR 812.150)

Recommendations are provided to help investigators identify the following:

  • 1. For drugs — Identify safety information that is considered an unanticipated problem involving risk to human subjects or others and that therefore requires prompt reporting to institutional review boards (IRBs) under § 312.66 (21 CFR 312.66</ul>
  • 2. For devices — Identify safety information that meets the requirements for reporting unanticipated adverse device effects (UADEs) to sponsors and IRBs under § 812.150(a)(1) (21 CFR 812.150(a)(1))

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2021-D-0368.

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