21 CFR 862.1357 — Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1357
Identification
The Eversense AP CGM System is a continuous glucose monitoring system (CGM) that provides glucose measurements every 5 minutes over a 40-400 mg/dL range. It consists of a glucose sensor (the Eversense AP Sensor) containing dexamethasone acetate, which is inserted under the skin; an externally worn Eversense AP Smart Transmitter; and the Eversense Mobile Medical Application (MMA). The system is indicated for continually measuring glucose levels for up to 6 months in people (18 years and older) with diabetes, to replace fingerstick blood glucose measurements for treatment decisions, and to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems.
Classification Rationale
Class II (special controls). The device is an integrated continuous glucose monitoring system (iCGM) with a sensor containing dexamethasone acetate, classified under 21 CFR 862.1357.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| SBA | Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate | 2 | 2 | SaMD, Implant |
Special Controls
SBA — Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
Dexamethasone acetate-eluting integrated continuous glucose monitoring systems must comply with the following special controls:
De Novo Order DEN230052
