Which is NOT required before starting a Non-Significant Risk device clinical trial?

The correct choice indicates that submission of the trial protocol to the FDA for approval is not required before starting a Non-Significant Risk (NSR) device clinical trial. NSR devices, by definition, are those that do not pose significant risk to participants, and therefore, the regulatory requirements are less stringent than for Significant Risk devices.

For NSR trials, the investigation generally only requires Institutional Review Board (IRB) approval, informed consent from participants, and financial disclosure by investigators to enhance transparency and manage potential conflicts of interest. This streamlined process allows for quicker initiation of studies that involve devices deemed to have lower risk factors, thus fostering innovation while maintaining the necessary ethical oversight and participant safety.

This framework reflects an understanding of the balance between regulatory oversight and the facilitation of clinical research for lower-risk medical devices.