Mobile Medical Applications

News & Analysis as of

Regulatory Landscape For Mobile Medical Apps (MMAs)

On December 6, 2013, I delivered a presentation on the FDA’s policy on mobile medical apps (MMA) to the Bar Association of Erie County. The event was well attended by attorneys practicing in diverse areas, including health,...more

FDA Enforcement Action Against uChek: Does It Signal an Agency Wake-up Call for Non-compliant Mobile Medical Apps?

In late May, the U.S. Food and Drug Administration took regulatory action against a mobile medical application or "mHealth" app for the first time. In its "It Has Come to Our Attention" letter to Biosense Technologies Private...more

The FDA Thinks Your Smartphone May Be A Medical Device

The Food and Drug Administration (FDA) has delivered on its promise to issue guidelines this year regarding “medical apps” that are being developed and issued daily across the United States. A press release regarding the...more

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