FDA product code QLF: On-Body Injector
QLF is the FDA product code for on-body injector. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel. Devices under QLF reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | On-Body Injector |
| Device class | Class II |
| Regulation | 21 CFR 880.5860 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | Contact FDA |
Recalls for QLF devices
openFDA lists no recalls for product code QLF.
Frequently asked questions
What is FDA product code QLF?
QLF is the FDA product code for on-body injector. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel.
What device class is QLF?
Class II, regulation 21 CFR 880.5860. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code QLF
- Run a recall and safety report across every QLF manufacturer
- Watch product code QLF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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