{"data":{"id":"us/21-cfr-862.2120","jurisdiction":"us","citation":"21 CFR 862.2120","heading":"Continuous glucose monitor data management system.","body":"(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.\n(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.","path":["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"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"def0540d24cbd1e4052627b66bdbd1975e4aa80047e6b6d41291eb8aad1de4b5","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.2100","next":"us/21-cfr-862.2140"},"notice":"GroundRules: Original legal text. Not legal advice."}