Safety Reporting - Responsibilities for Investigational Drugs and Devices

The U.S. Food and Drug Administration, FDA, published a new guidance on the responsibilities regarding safety reporting for investigational drugs and devices. The guidance is intended to help clinical investigators comply with the safety reporting requirements for:

  • Investigational new drug application (INDA) studies,
  • Investigational device exemption (IDE) studies.

Recommendations are provided to help identify the following:

  • Safety information for Drugs which is considered an unanticipated problem involving risk to human subjects or others and therefore requires prompt reporting to institutional review boards (IRBs);
  • Safety information for Devices which meet the requirements for reporting unanticipated adverse device effects (UADEs) to sponsors and IRBs.

What is an UADE?

This is expected to vary depending on the specific device and the way the device is used within the study. Thus, sponsors are required to include risk information in the investigational plan, which may help investigators identify and assess potential UADEs

IDE studies: What is required? 

Investigators are required to submit a report of UADEs to the sponsor and the reviewing IRB as soon as possible, but in no event later than 10 working days after the investigator finds out about the effect. Sponsors must immediately conduct an evaluation of the UADE and must report the results of the evaluation to FDA, reviewing IRBs, and participating investigators within 10 working days after the sponsor received notice of the effect.

Moreover, investigators are to provide progress reports to sponsors, monitors, and IRBs at regular intervals, and no less than yearly. Such reports should provide information to sponsors about both anticipated and unanticipated adverse device effects.

For more information please see FDA´s draft guidance Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices.

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