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# Insulin Therapy Adjustment Devices into Class 2
- URL: https://www.fdaweb.com/insulin-therapy-adjustment-devices-into-class-2/
- Published: 2018-11-01T12:00:00.000Z
- Updated: 2026-09-15T00:42:01.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142723

*Federal Register* notice: FDA has classified insulin therapy adjustment devices into Class 2 (special controls). The action follows a DreaMed Diabetes *de novo* classification request for its DreaMed Advisor Pro. Such devices are identified as intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens for patients with diabetes mellitus. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-11-01/pdf/2018-23912.pdf?ref=fdaweb.com).