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Introduction to Investigational Device Exemptions (IDEs)

An Investigational Device Exemption (IDE) is a request for authorization by the Food and Drug Administration to evaluate an investigational device in humans in order to collect safety and effectiveness data to support a Premarket Approval (PMA) application or a Premarket Notification (510[k]) submission to the FDA.

This authorization, unless deemed unnecessary, must be obtained prior to interstate shipment of the device and its evaluation in humans.

FDA regulations governing the IDE process, investigator and sponsor obligations, compliant performance of clinical research, annual reporting, safety reporting, etc are contained in Title 21, Code of Federal Regulations, Part 812

Clinical evaluation of devices that have not been approved requires:

  • An IDE approved by an institutional review board (IRB; at Dartmouth, this is the Committee for the Protection for Human Subjects, CPHS). If the study involves a significant risk device, the IDE must be approved by the FDA. See Guidance: http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126418.pdf
  • Informed consent from all subjects prior to use of the device.
  • Labeling for investigational use only.
  • Monitoring of the study.
  • Required records and reports.

An overview of Device Regulation and Guidance is available at http://www.fda.gov/medicaldevices/deviceregulationandguidance/default.htm 

Guidance Documents for Clinical Trials and IDEs are available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIDE/daIDEgd_print.cfm

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