The Need for More Balanced Enforcement of Mobile Medical App Regulations In this 2-minute audio snippet, Bradley Merrill Thompson, Member of the Firm at Epstein Becker & Green and General Counsel to the mHealth Regulatory Coalition, describes a urine analysis mobile app that illustrates why the mobile health app industry needs more consistent and balanced FDA enforcement of mobile regulations.
Your browser does not support the audio element. Upgrade your browser to one that does
Thompson points out that the app declared itself NOT to be a medical device. “If only it were that simple,” said Thompson.”
- How Did the uChek iPhone Urine Analysis App “Come to FDA’s Attention?” – Blog post
- Beyond Mobile Medical App Guidance: What to Worry About After FDA Publishes Its “Final” Guidelines – PMT podcast