An IDE is required for all medical devices that are considered significant risk devices. Guidance is available for sponsors and IRBs on what constitutes a significant risk device. Under the guidance, a significant risk (SR) device:

• “Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
• Is purported or represented to be for use supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
• Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
• Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.”

Not surprisingly, a non-significant risk (NSR) device is one that does not meet the definition of an SR device.

Clinical studies with SR devices must follow all the regulations for an investigational device exemption (IDE, see my previous post on this topic) and sponsors must have an approved IDE application before proceeding with an SR device study. NSR devices do not require an approved IDE application and are subject to abbreviated requirements such as labeling, IRB (Investigational Review Board) approval, informed consent, monitoring, records, reports, and prohibition against promotion. Significantly, NSR device studies do not need to be reported to the FDA, and such a study may start as soon as the overseeing institution’s IRB reviews and approves the study. In effect, the IRB stands in for the FDA on an NSR device study. This means the IRB has considerable responsibility for making the risk determination for devices that sponsors submit for NSR studies, and the guidance is very much focused on that responsibility.

Text Copyright © 2019 Katrina Rogers