QLF
- Product code
- QLF
- Device name
- On-Body Injector
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5860
- Medical specialty
- General Hospital
- Marketing pathway
- Contact ODE
FDA classification 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.
Official FDA classification page: QLF
Classification and pathway per current FDA publications. Data from openFDA (CC0).