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All subjects must be adults aged 18 years and older

As a general matter, any clinical investigation of a device — that is, any study involving one or more subjects to determine the safety or effectiveness of a device — must have an approved IDE or qualify for an exemption from the IDE requirements before it may lawfully be conducted in the United States

For such studies, the sponsor must submit a complete IDE application to FDA in accordance with 21 C

Instead, the sponsor must comply with certain specified provisions of Part 812, including requirements for informed consent (21 C

While the energy levels involved are low and are not expected to present a meaningful risk to subjects, these features must be considered in the overall SR/NSR analysis

As part of its review and approval of the study, Clearwater IRB will be required to evaluate the following: • Solstice's risk assessment and NSR determination, including the rationale for concluding that the Lumina CGM System does not present a significant risk to study subjects; • The investigational plan (Protocol SBD-LUM-CL-001), including the study design, primary and secondary endpoints, inclusion and exclusion criteria, study procedures, and data analysis plan; • The informed consent documents, which must comply with the requirements of 21 C