Q&A: McDermott’s Vernessa Pollard on Health IT and FDA Regulation

Overview


Vernessa Pollard, who has a focus on health information technology as new co-head of the FDA practice, said “the primary legal issue” for health IT is “whether these technologies are medical devices regulated by FDA.” Ms. Pollard noted that the FDA has issued guidance on what it will not regulate, but added that for “apps that are actually replicating the same kinds of functions as a traditional medical device,” the agency views them “in the same way that it would regulate the traditional medical device that does the same thing.”