GroundRules
21 CFR 862.2120: Continuous glucose monitor data management system.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
- Subpart C—Clinical Laboratory Instruments
(a) 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.
(b) Classification. 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.
Collected 2026-08-27T02:24:47Z. Source file · JSON