Regulatory challenges and investigational device exemption protocols for fenestrated and branched EVAR in the United States.

The US Food and Drug Administration (FDA) was created with the intent to ensure the safety of consumers in the United States. During the 1970s, this mandate was expanded to include medical devices. Aortic endografts, implanted since the 1990s, fall under this purview. Industry-sponsored and physician-sponsored investigation of the efficacy and safety of these devices is critical to the ongoing development of interventions for complex aortic anatomy. This research, in accordance with federal rules and regulation, must be conducted in coordination and with the approval of the FDA. The FDA has designed a process for which manufacturers or investigators may conduct efficacy and safety research using new or modified devices with oversight by the federal government. To conduct this type of research, an investigational device exemption must be obtained from the FDA. An investigational device exemption, although useful from a regulatory perspective, places a large time and financial responsibility on the investigator. As it stands now, the regulatory environment limits research into fenestrated and branched endovascular aortic repair to only those physicians and manufacturers able to provide the significant number of resources required to complete the laborious pre-application, application, and ongoing reports associated with obtaining and maintaining an investigational device exemption.