Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in BNA Snapshot, in “FDA Issues New Guidance; Won’t Regulate Low-Risk Device Data Systems,” by Nathaniel Weixel.
Following is an excerpt:
Bradley Merrill Thompson, an attorney with Epstein Becker & Green PC in Washington, and one of the organizers of the mHealth Regulatory Coalition, told Bloomberg BNA the MDDS guidance shows the FDA is “sticking to its word” by working to down-classify or altogether exempt low-risk software-based technologies.
“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.