21 CFR 862.2120 — Continuous Glucose Monitor Retrospective Data Analysis Software

Clinical Chemistry (CH) · Part 862 Subpart C—Clinical Laboratory Instruments · § 862.2120

Identification

A continuous glucose monitor data management system is an electronic device intended to acquire, process, and correlate retrospective data from a continuous glucose monitoring device. This device is intended to be used by patients or their healthcare providers when determining therapeutic strategies. A continuous glucose monitor data management system is not a drug dose calculator and does not provide treatment recommendations.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 862.9.

Product Codes