QLF · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5860
Classification
FDA Product Code
QLF
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.5860
Review panel
HO
Medical specialty
General Hospital
Submission type
3
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.