FDA Product Code QRX: Continuous Glucose Monitor Informed Insulin Dose Calculator
FDA product code QRX covers CGM-informed insulin dose calculators that use continuous glucose monitoring data to assist insulin dosing decisions.
These software algorithms incorporate current CGM glucose values, rate of change, and trend data to calculate a suggested insulin dose, providing an additional layer of decision support for patients and clinicians managing insulin therapy.
QRX devices are Class II medical devices, regulated under 21 CFR 862.1358 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Insulet Corporation and Dexcom, Inc..
FDA 510(k) Cleared Continuous Glucose Monitor Informed Insulin Dose Calculator Devices (Product Code QRX)
About Product Code QRX - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code QRX since 2022, with 5 receiving FDA clearance (average review time: 188 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under QRX have taken an average of 75 days to reach a decision - down from 216 days historically, suggesting improved FDA processing for this classification.
QRX devices are reviewed by the Chemistry panel. Browse all Chemistry devices →