(a) Identification. An insulin therapy adjustment device is a device intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens for patients with diabetes mellitus.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Design verification and validation must include the following:

(i) A complete description of the required data inputs, including timeframe over which data inputs must be collected and number of data points required for accurate recommendations;

(ii) A complete description of the types of device outputs and insulin therapy adjustment recommendations, including how the recommendations are generated;

(iii) Robust data demonstrating the clinical validity of the device outputs and insulin therapy recommendations;

(iv) A robust assessment of all input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs, to ensure accurate and reliable therapy adjustment recommendations. This assessment must include adequate clinical justification for each specification;

(v) A detailed strategy to ensure secure and reliable means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures;

(vi) Robust data demonstrating that users can understand and appropriately interpret recommendations generated by the device; and

(vii) An appropriate mitigation strategy to minimize the occurrence of dosing recommendation errors, and to mitigate the risk to patients of any residual dosing recommendation errors to a clinically acceptable level.

(2) The device must not be intended for use in implementing automated insulin dosing.

(3) Your 21 CFR 809.10(b) labeling must include:

(i) The identification of specific insulin formulations that have been demonstrated to be compatible with use of the device;

(ii) A detailed description of the specifications of compatible devices that provide acceptable input data (e.g., continuous glucose monitors, insulin pumps) used to provide accurate and reliable therapy adjustment recommendations;

(iii) A detailed description of all types of required data (inputs) and dosing recommendations (outputs) that are provided by the device; and

(iv) A description of device limitations, and instructions to prevent possible disruption of accurate therapy adjustment recommendations (e.g., time zone changes due to travel).