Understanding the FDA Process Is Critical for Young Companies.

Abstract

Our team recently led our augmented reality preoperative planning software application through Food and Drug Administration 510(k) clearance as a class 2 medical device. As augmented and virtual reality play an increasing role in health care, more early-stage companies will be required to seek this clearance. Often founders at these companies lack regulatory experience, which can make the process difficult and inefficient. Our experience was the first time for us. For those in a similar position, it's important to keep a few things in mind that can help lead to a successful process.