FDA Product Code QOG: Injection Data Capture Device
An Injection Data Capture Device Is An Electrically-powered/electromechanical Accessory That Interfaces With Reusable Or Disposable Injection Devices For The Purposes Of Interpreting, Recording And Displaying And/or Transmitting Injection Data To A Connected Application Or Software.
Leading manufacturers include Biocorp Production, Eli Lilly and Company and Insulcloud S.L..
FDA 510(k) Cleared Injection Data Capture Device Devices (Product Code QOG)
About Product Code QOG - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code QOG since 2022, with 7 receiving FDA clearance (average review time: 156 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QOG have taken an average of 92 days to reach a decision - down from 241 days historically, suggesting improved FDA processing for this classification.
QOG devices are reviewed by the General Hospital panel. Browse all General Hospital devices →