Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice in the Washington, DC, was quoted in an article titled “Radiology mobile app Mobile MIM’s long, strange FDA trip.”
The article discussed how a software company finally obtained FDA clearance for its Mobile MIM app, nearly three years and three 510(k) applications. This is the first-ever radiology mobile app to receive the agency’s seal of approval.
Clearance of this technology is a big step toward [the FDA] developing a model to review the next technology that comes down the pike. And there will be a next technology,” said Thompson.
Thompson said the uncertainty surrounding the FDA’s regulation of mobile health apps is indicative of a “culture clash” between the Rockville, Maryland-based agency and software developers’ Silicon Valley ethos. The regulatory process is moving “very fast in Rockville terms, but very slow in Silicon Valley terms,” he said. “Silicon Valley is just not used to working in the public health environment, so it’s a difficult learning curve.”