| Device |
on-body injector |
| Regulation Description |
Piston syringe. |
| Definition |
An On-Body injector is a prescription device adhered to the body intended to inject single or multiple doses of medicinal product from a cartridge or reservoir in accordance with FDA approved labeling. The device can be used by health care professionals or for self-injection by the patient. It should not be used for the infusion of drugs. |
| Physical State |
The On-body injector includes the delivery device and reservoir or cartridge, and may contain accessories needed to assist the user in filling the device with FDA approved drugs, or the device may be designed to accept prefilled drug containers that are intended for use with the device. The device is worn directly on the body. It is constructed of a variety of polymeric materials and may include software to activate and/or deliver the medication. It should not be used for the infusion of drugs. |
| Technical Method |
While adhered to the body, the On-body injector injects a specific drug subcutaneously in accordance with FDA approved labeling. |
| Target Area |
Subcutaneous tissue. The device is generally targeted for use on the abdomen, buttock, back of the arm or other location acceptable for the subcutaneous delivery of drugs and device placement in accordance with FDA approved labeling. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | QLF |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
| Submission Type |
Contact ODE
|
|---|
| Regulation Number |
880.5860
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
