QLF — On-Body Injector Class II
FDA product code QLF covers "On-Body Injector", a Class II medical device regulated under 21 CFR 880.5860. Submissions are reviewed by the General Hospital panel.
Classification Details
- Product Code
- QLF
- Device Class
- Class II
- Regulation Number
- 880.5860
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.