Extract to table

The special controls establish the performance, design, clinical evidence, labeling, software, cybersecurity, and quality system requirements that an iCGM device must satisfy in order to provide reasonable assurance of safety and effectiveness

First, it describes the analytical accuracy performance criteria that iCGM devices must meet, including the overall MARD threshold, point accuracy requirements, and glucose range-specific performance benchmarks

Third, the guidance describes the data output requirements for interoperability, specifying the format and content of glucose data that an iCGM must provide to secondary devices

This threshold reflects FDA's assessment that CGM data used to drive automated insulin dosing decisions must meet a higher accuracy standard than CGM data used solely for informational purposes

Achieving this target will be critical to iCGM classification, and Solstice should be aware that the MARD target is not simply a mean performance goal but must be demonstrated with statistical rigor across the full measurement range and across the full sensor wear duration

In addition, MARD performance must be maintained across the full fourteen (14)-day sensor wear duration (336 hours) of the Lumina C14 sensor