GUIDANCE DOCUMENT
Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices Draft Guidance for Industry September 2021
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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Dockets Management
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All written comments should be identified with this document's docket number: FDA-2021-D-0368
- Docket Number:
- FDA-2021-D-0368
- Issued by:
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Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological HealthCenter 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))