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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device on-body injector
Regulation Description Piston syringe.
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.
Product CodeQLF
Regulation Number 880.5860
Device Class 2

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