In The Sound of Music, Maria taught the Von Trapp children that reading starts with A-B-C, and singing with do-re-mi.
If only deciphering the differences between FDA submission pathways were that simple.
There are several options, each with their own standards and documentation requirements.
A pre-market approval, or PMA, can require up to thirty three-ring binders’ worth of data. That’s a LOT of data.
510K submissions require proof of substantial equivalence to an approved product or method already on the market.
Thirty three-ring binders? Substantial equivalence? Evidence of safety and efficacy? Do you feel a headache coming on, just thinking about all this?
Relax. I am a trained professional, and I can ease your stress with a simple phone call.
Find some time on my calendar and we’ll talk about the submission pathway that best fits your device. And THAT is a very good place to start.