who is responsible for making the initial risk determination for a device being used in a study?

For a medical device being used in a clinical study, the sponsor (often the sponsor‑investigator) is responsible for making the initial risk determination for that device and then presenting that determination to the Institutional Review Board (IRB).

Core responsibility

Regulatory guidance on significant risk (SR) versus nonsignificant risk (NSR) device studies states that the study sponsor must propose the initial risk classification of the device used in the study. This means the sponsor‑investigator evaluates how the device will be used in the protocol and categorizes the study as SR or NSR before IRB review.

Role of the IRB and FDA

After the sponsor makes this initial determination, the IRB must review that assessment and either agree or disagree as part of its initial ethical and regulatory review of the study. If needed, FDA can assist the sponsor and IRB and serves as the final arbiter when there is uncertainty or when FDA has already issued a risk determination for that device study.

Quick recap

• Initial risk determination: Sponsor/sponsor‑investigator.

• Review and concurrence/nonconcurrence: IRB.

• Final say if questions remain or prior decision exists: FDA.

Information gathered from public forums or data available on the internet and portrayed here.