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 Venture Beat, in “FDA Makes Official Its Hands-Off Approach to Regulating Health Apps and Medical Software,” by Mark Sullivan.
Following is an excerpt:
“FDA is certainly sticking to its word, working to down-classify or altogether exempt low-risk software-based technologies,” said our go-to FDA regulation specialist, attorney Brad Thompson, who works with medical devices makers to navigate the sometimes tricky FDA regulatory waters.
Thompson said today’s news is big for the health tech industry. “The implications are profound, both for MDDS-type software, but also for what it suggests about the future for health information technology generally,” he said. “FDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software.”