Bradley Merrill Thompson Quoted in an Article About FDA’s Proposed Guidance for Certain Mobile Medical AppsMedscape Today News July 20, 2011
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "FDA Proposes Guidance for Certain Mobile Medical Apps."
Following is an excerpt:
In draft guidance, the US Food and Drug Administration (FDA) proposed limiting the scope of mobile medical applications (apps) it plans to regulate to a small subset of apps that either affect or may affect the performance or functionality of currently regulated medical devices.
The news pleased wireless medicine experts. "It's a step...in the right direction," said Bradley M. Thompson, general counsel for the mHealth Regulatory Coalition, a temporary group of stakeholders including manufacturers and provider groups created to offer the FDA advice on what should be regulated.
Thompson hoped the final guidance will contain more detail. He would like to see more delineation of the difference between a mobile app for general health and wellness vs one for the treatment of a disease. As we learn how diet, exercise, and sleep affect many chronic diseases, it can be hard to draw the line between something that is FDA regulated and something that is not, he said.