Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in Bloomberg BNA’s Medical Devices Law & Industry Report, in “FDA Won't Regulate Medical Device Data Systems.”
Following is an excerpt:
Bradley Merrill Thompson, an attorney with Epstein Becker & Green PC in Washington, told Bloomberg BNA the guidance shows the FDA is “sticking to its word.”
“The implications are profound, both for MDDS type software, but also for what it suggests about the future for health information technology generally. FDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software. It's exciting, because it means that innovation in this space can truly flourish,” Thompson said in an e-mail.