Table 1.

Regulatory Categories for Interoperable Diabetes Devices.

Device	De Novo classification	Code of federal regulations
Integrated continuous glucose monitor (iCGM)	DEN170088, March 27, 2018	21 CFR 862.1355
Alternate controller-enabled (ACE) pump	DEN180058, February 15, 2019	21 CFR 880.5730
Interoperable automated glycemic controller (iAGC)	DEN190034, December 13, 2019	21 CFR 862.1356

Abbreviations: ACE, alternate controller-enabled; CFR, code of federal regulations; DEN, De Novo; iAGC, interoperable automated glycemic controller; iCGM, integrated continuous glucose monitor.