Computer Vision News - October 2019

Helping Companies with FDA 10 I am sure you also have post- market experience. Is that right? Yes, there are also requirements that apply to medical devices after they are on the market. There are quality systemrequirementsandadvertising and promotion issues. There is diligence for corporate deals. There are lots of things in this industry that we end up touching. I actually also have a sub-specialty in the area of radiation-emitting products, whether or not they are medical devices. I do a lot of work with products like lasers and ultrasound that may or may not be a medical device. FDA actually regulates that whole area as well, even if it is not a medical product. Currently, I have a few projects working completely outside of the medical area on autonomous vehicles. You also had a stint at the FDA, so you know these kinds of projects on both sides. Yes, I was at the FDA very briefly. Can you tell our readers about your work? I work helping medical device companies navigate the FDA regulatory process. That involves anything from regulatory strategy in designing what indications and technology to bring forth to the agency and the data that will be required to support any applications. I also work directly on the technical applications with the FDA including 510(k) notices, De Novo requests, andpremarketapprovalapplications. Also, requests to initiate clinical studies through the IDE process and also pre submissions when you have the opportunity to go in and meet with FDA to talk about your device, your strategy, the data that you will collect for your application and make your argument to the agency. There are a lot of other regulatory and business considerations that go along with that process too. Navigate the FDA Regulatory Process wi th Lina Kontos