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U.S. Department of Health and Human Services

Product Classification

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Device injection data capture device
Definition 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.
Physical State An injection data capture device may consist of an attachable add-on device that a user attaches to the injection device or could be manufactured directly into the injection device. The device may be single or multi-component and includes electromechanical hardware and software to allow for the detection, transmission and/or display of injection data.
Technical Method Injection data capture devices are operated manually or automatically to detect injections and record injection data. This can include the ability to detect the amount of dose dialed/administered, detect day/time of dose, or other injection data (e.g., detect prime/no-prime events). This data can be displayed on the injection data capture device directly and/or transmitted to a connected software or mobile application via wired or wireless methods.
Target Area Injection data capture devices do not have a target area but are instead intended to interface with injection devices.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeQOG
Premarket Review Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible