Computer Vision News - October 2019

Application Helping Companies with FDA 12 to be from the FDA side in terms of data collection and regulatory filings and trying to make strategic decisions regarding when to talk to FDA, what to tell them, and where that fits in the development plan regarding how to get to market. Companies never have one product either. They are working towards a whole platform of technology. Their first touch with FDA is likely just the first step in what is going to be a long relationship with the agency. What is the most frequent mistake people make? I think it varies. There are a couple of things that we see often. One of them is not taking a step back in engaging with FDA early enough. What ends up happening is that people are anxious to get to market or to collect data. Then they think that data is going to be sufficient to support a complex device submission. FDA often really has strong preferences about what should go into clinical studies and evaluations, especially with novel products in this space. I think it is always helpful to have an early touch with the agency, particularly for novel devices, and go in and present your technology to them in a plan regarding how you plan to study the device and collect that data. That gives the agency the opportunity to comment on it so that There seems to be conflicting interests between the public's need for additional controls and studies and the company’s preferenceforbringingproducts to the market faster with the least possible obstacles. There is always a bit of a conflict, especially in the medical device areas as companies are striving to bring products to market and have to address regulatory requirements. However, the companies are founded on helping the public, too. The goal is always for public safety both on FDA’s side and the company side. They are each working towards helping people. That is what medical device companies do in this space. In that sense, I think they are working towards the same goal. It is just a matter of what are going to be the checkpoints along the way. Obviously, particularly with startups, there is new and exciting technology out there and interest to get to market. We help companies navigate that process, trying to figure out what the burden is going "Typi cal l y FDA wants every thing to be ver i f i ed and val idated on a f inal locked des ign"