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• Several material documentation gaps have been identified that must be remediated prior to the 510(k) submission

Given the requirements of FDA's September 2023 cybersecurity guidance, the absence of SBOMs represents a submission-blocking deficiency that must be addressed as a matter of first priority

This memorandum identifies areas where Pinnacle's workstreams and Solstice's internal engineering documentation must be aligned

All software documentation for the Lumina CGM System must comply with this guidance

All of these documents must be provided for each of the four software components

1 — Software Development Planning: Solstice must maintain a documented software development plan covering all aspects of the development lifecycle