Who is responsible for making the initial risk determination for a device in a study?

The initial risk determination for a device in a study is primarily the responsibility of the sponsor-investigator. This individual or entity is engaged in the clinical investigation and holds the responsibility to assess the risks associated with the device based on available data, prior studies, and the intended use of the device. The sponsor-investigator must evaluate potential risks to ensure the safety of participants involved in the study.

While the Institutional Review Board (IRB) does play a significant role in reviewing studies and ensuring ethical standards are upheld, the IRB's function follows the initial risk determination made by the sponsor-investigator. The FDA is involved in the regulatory oversight and review process but is not responsible for the initial risk assessment. The manufacturer of the device may provide safety and efficacy data that inform the risk assessment, but ultimately, it is the sponsor-investigator who synthesizes that information to determine initial risk for the study participants.