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 Warns Mobile Health Apps Makers."
Following is an excerpt:
The Food and Drug Administration (FDA)'s letter admonishing an Indian software developer that it needs FDA clearance for its urinalysis app is a warning to other mobile health firms marketing apps that could be construed as medical devices.
But the FDA's action alone does not establish which kinds of apps could be regulated, noted Bradley Thompson, an attorney ... who is an expert on mobile health regulations. In fact, even the FDA's final guidance on mobile health apps, which is due this fall, will not settle some of the most important issues in this area, Thompson told InformationWeek Healthcare.
