Computer Vision News - October 2019

There are a couple areas of technology where, for example in the product radiation. If you emit radiation, that gets somewhat more complicated with the importation process. The FDA will treat each company the same way. I think where there is a difference is not in terms of the regulatory burdens on the companies, but in terms of how data is collected. If there is a clinical study requirement to support the device, because you are seeking FDA approval for the US, FDA wants you to explain that the device works in the US population. The US population may not represent or be reflective of the population outside of the US in terms of gender, body mass, and race. That is where I think some challenges come in for overseas companies is making sure clinical data collected overseas could support the US population. Companies are always free to conduct studies in the US as well. There is no additional burden there for a foreign company compared to a US company conducting the same study in the US. Helping Companies with FDA 14 "FDA of ten real l y has s t rong preferences about what should go into c l ini cal s tudi es and evaluat ions " Can you tell me one example, without names of course, that you found that FDA was extremely attentive to be fair with the company and the device being judged? I think the FDA is really interested in devices for unmet needs, rare disease populations, and pediatric populations. At the same time, they are going to be very cautious. There are a lot of risks with these populations as well. The agency is very interested in working with companies who are trying to come up with innovative solutions. There is not always a big monetary market in this area, and FDA understands that. There is not always a lot of innovation in these areas because there is not always a financial incentive for companies. There is still a great clinical and medical need and the FDA is really trying to work with companies in those specific areas.