It is amazing to me a simple piston syringe, with or without a needle requires a 510K. And if you are a unit dose device, an NDA will be required. All pertinent information on submissions will be on fda.gov.
If you are going into the field, you’ll need credentialing through VendorMate, MedReps and a third one that escapes me. You have to update once a year for all three with shots and documentation of shots.
For any 510K or NDA most of the 1-5 years it will take to launch a product will be used on testing and trials. I would highly suggest speaking with your regulatory group on finding a way to say yes (they typically say no) to trying product on people in the field. I can’t tell how many bad ideas come out of the lab, untested on actual users, that get rammed through because of the high cost of investment only to miserably fail in sales. That company will quickly become a follower.
What typically happens in the medical field, you’ll have the leaders, with a good innovation system, and the followers who knock-off the innovators. There are only a few innovators and being in the NPD group of a follower sucks.