On-Body Injector
The On-Body Injector is a Class 2 general hospital prescription device that adheres to the body and is intended to inject single or multiple doses of a medicinal product from a cartridge or reservoir in accordance with FDA-approved labeling, suitable for use by healthcare professionals or for patient self-injection, but not intended for continuous drug infusion. It requires 510(k) clearance and is regulated under 21 CFR 880.5860 within the General Hospital medical specialty. The product code is QLF. The device is not an implant and is not flagged as life-sustaining.
Basic Information
- Product Code
- QLF
- Device Class
- FDA class 2
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 3
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.