Contract analysis

I. Executive Summary The purpose of this memorandum is to analyze whether the planned LUMINA-US clinical study (Protocol SBD-LUM-CL-001) qualifies for the Investigational Device Exemption ("IDE") exemption under 21 C.F.R. § 812.2(c)(3) as a non-significant risk ("NSR") diagnostic device study, thereby avoiding the need for FDA IDE application approval prior to commencing the study. This analysis was undertaken at the

II. Background A. The Solstice Lumina™ CGM System The Solstice Lumina™ CGM System ("Lumina CGM System" or the "System") is a next-generation continuous glucose monitoring system designed, developed, and manufactured by Solstice Biomedical Devices Ltd., a company incorporated and headquartered in Galway, Ireland, with U.S. operations conducted through its wholly owned subsidiary, Solstice Biomedical Inc., located in S

III. Legal Framework: IDE Requirements and Exemptions A. Overview of IDE Regulations (21 C.F.R. Part 812) The Investigational Device Exemption regulations, codified at 21 C.F.R. Part 812, govern the conduct of clinical investigations of medical devices intended for human use. The statutory basis for these regulations is found in Section 520(g) of the Federal Food, Drug, and Cosmetic Act ("FD&C Act"), 21 U.S.C. § 360j

Section 812.1 of the IDE regulations sets forth the purpose and scope of Part 812, stating that the regulations are designed "to encourage, to the extent consistent with the protection of the public health and safety and with ethical standards, the discovery and development of useful devices intended for human use." The regulations accomplish this purpose by establishing a framework under which investigational device

1. The device is being tested in compliance with applicable provisions of 21 C.F.R. Part 809 (in vitro diagnostic products for human use), if applicable to the particular device or investigation;

2. The testing is noninvasive, or if the device is invasive, the investigation does not by its nature present a significant risk to the subject beyond the risks inherent in the diagnostic procedure itself;

3. The testing does not require an invasive sampling procedure that presents a significant risk to the subject;

4. The testing does not, by design or intention, introduce energy into a subject; and

5. The testing is not used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure. The critical nuance of § 812.2(c)(3) lies in the interplay between the "noninvasive" condition and the "energy introduction" condition. The provision was principally designed to address in vitro diagnostic testing, where a specimen has been collected from a patie

IV. Application to the LUMINA-US Study A. Analysis of 21 C.F.R. § 812.2(c)(3) Diagnostic Device Exemption The threshold question is whether the LUMINA-US study qualifies for the diagnostic device exemption under 21 C.F.R. § 812.2(c)(3), which would exempt the study from the full scope of IDE requirements, including both the full IDE requirements applicable to SR studies and the abbreviated IDE requirements applicable

V. Obligations Under the NSR abbreviated IDE Even though the LUMINA-US study is expected to qualify as an NSR study and the § 812.2(c)(3) diagnostic device exemption does not strictly apply, the abbreviated IDE requirements under 21 C.F.R. § 812.2(b) impose substantive compliance obligations that Solstice must satisfy throughout the duration of the study. Failure to comply with these requirements could result in FDA

VI. Recommendation A. Primary Recommendation Based on the analysis set forth in this memorandum, Calderwood & Harkness concludes that the LUMINA-US clinical study (Protocol SBD-LUM-CL-001) likely qualifies as a non-significant risk (NSR) diagnostic device study under the abbreviated IDE framework of 21 C.F.R. § 812.2(b). The strict diagnostic device exemption under 21 C.F.R. § 812.2(c)(3) may not fully apply to the L