Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was featured in Clinical Innovation & Technology, in an article titled “Navigating FDA Regulations of Medical Software.”
Following is an excerpt:
Permitted functionalities include promoting, tracking, and/or encouraging healthy choices. The functions have to be low risk, however. An app to help people with diabetes, for example, doesn’t treat the disease. “There’s a gentle, subtle line here,” Thompson said. “It has to be good for general health and not crossing the line and saying in the app or promotion of the app that it’s good for managing diabetes.” The seriousness of disease has a major impact on how the FDA will treat the products, he noted.
The article was based on remarks Mr. Thompson recently gave at the 2015 World Congress mPharma Summit.