Combination product of investigation: Epinephrine auto-injector (injection pen)

This device is intended to inject epinephrine directly into the patient’s body during an allergic reaction for most rapid response time. Epinephrine causes the body to delay/ stop anaphylaxis caused by the initial allergen, exercise, or other trigger therefore potentially saving the patient’s life. The delivery vessel is the needle; however, the primary method of action (PMOA) of this device is the drug epinephrine which causes CDER to be the lead agency. Lastly, the submission pathway most applicable for this combination device would be a New Drug Application (NDA) or an appropriate filling of a 505(b)2.

https://www.meddeviceonline.com/doc/how-to-determine-a-combination-product-s-primary-mode-of-action-pmoa-0001
https://www.drugs.com/epipen-auto-injector.html