IDE Approval Process: Significant Device Risk Studies

A significant risk device presents a potential for serious risk to the health, safety, or welfare of a subject. Significant risk devices may include implants, devices that support or sustain human life, and devices that are substantially important in diagnosing, curing, mitigating or treating disease or in preventing impairment to human health. Examples include sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants.

Studies of devices that pose a significant risk require both FDA and an Institutional Review Board (IRB) approval prior to initiation of a clinical study. FDA approval is obtained by submitting an IDE application to FDA.

In order to conduct a significant risk device study, a sponsor must:

• submit a complete IDE application to FDA for review and obtain FDA approval of the IDE; submit the investigational plan and report of prior investigations to the IRB at each institution where the investigation is to be conducted for review and approval; and
• select qualified investigators, provide them with all necessary information on the investigational plan and report of prior investigations, and obtain signed investigator agreements from them.