Computer Vision News - October 2019

11 Lina Kontos I worked in the FDA in the peripheral vascular devices branch, which is in the division of cardiology before coming over to Hogan Lovells. I have been at Hogan Lovells almost 13 years now. This puts you in the ideal position to advise companies about how to approach the FDA and get approvals. Absolutely, we work as a firm and work with probably about 700 to 1,000 medical device clients. We are the biggest FDA group of any law firm or probably even consulting. We have about 25 attorneys and regulatory specialists dedicated to medical device issues. On any given day, I am working with 10 different clients across the medical device space. I am up at FDA a couple times a month talking with the agency in meetings. We are very familiar with how FDA operates and the data that will be required to support clearance or approval of each individual device. Is it true that the FDA is giving more and more attention to the specific area of artificial intelligence? Hogan Lovells has worked on a number of De Novo requests that have been granted in the AI Medical Imaging space. The FDA has now issued a few discussion papers talking about how they are planning to approach the regulatory efforts around this technology. It is still very much in development, and the space is somewhat contrary to how FDA has previously approached medical devices. We can get into the specifics of that, but typically FDA wants everything to be verified and validated on a final locked design. This is not really the intent of machine learning technology [laughs], which is intended to be adaptive and constantly improving. So FDA is trying to figure out the line of what companies and devices will beallowed to improveuponafterFDA has cleared or approved a product versus what a company would need to come back into FDA to seek a new application, a new 510(k) or De Novo, a PMA, or a supplement for improvements that have been based on real-world information. "On any gi ven day , I am working wi th 10 di f ferent c l i ent s across the medi cal dev i ce space . "