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IDE Safety Reports

The sponsor of an IDE is required to promptly review and report to the FDA and investigators all information relevant to the safety of the investigational device from any source, foreign or domestic (Table 1). The investigator also is required to review and report to the FDA and the manufacturer all information relevant to the safety of the investigational device (Table 2). The investigator will also need to report to CPHS.

Each written notification of an unanticipated adverse device effect (UADE) must be submitted on FDA Form 3500A. FDA Form 3500A and instructions can be accessed and submitted electronically on the FDA webpage Instructions for Completing Form FDA 3500A. If the FDA determines that additional data are needed, it will contact the sponsor.

Table 1: Summary of Reporting Requirements for Manufacturers

Reporter What to Report Report Form # To Whom When
Manufacturer 30-day reports of deaths, serious injuries and malfunctions Form FDA 3500A FDA Within 30 calendar days from becoming aware of an event
Manufacturer 5-day reports on events that require remedial action to prevent an unreasonable risk of substantial harm to the public health and other types of events designated by FDA Form FDA 3500A FDA Within 5 work days from becoming aware of an event
Manufacturer Baseline reports to identify and provide basic data on each device that is subject of an MDR report. At this time, FDA has stayed the requirement for denominator data requested in Part II, Items 15 and 16 on Form 3417. Form FDA 3417 FDA With 30 calendar, and 5 work day reports when device or device family is reported for the first time. Interim and annual updates are also required if any baseline information changes after initial
Manufacturer Annual Certification Form FDA 3381 FDA Coincide with firm's annual registration dates.

Table 2: Summary of Reporting Requirements for Investigator

Reporter What to Report Report Form # To Whom When
Investigator Death Form FDA 3500A FDA, Manufacturer, and CPHS Within 10 work days (FDA and Manufacturer)
Investigator Serious injury Form FDA 3500A Manufacturer and CPHS. FDA only if manufacturer unknown Within 10 work days (FDA or Manufacturer)
Investigator Annual reports of death and serious injury Form FDA 3419 FDA January 1
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