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Nossaman LLP

FDA Policy for Mobile Medical Applications

Nossaman LLP on

The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify...more

Morgan Lewis

FDA Issues Long-Awaited Final Guidance on Mobile Medical Applications

Morgan Lewis on

Agency expands enforcement discretion, focusing its oversight on a discrete subset of mobile apps that present the greatest risk to patients. On September 23, the U.S. Food and Drug Administration (FDA or the Agency)...more

Sheppard Mullin Richter & Hampton LLP

The FDA Releases Long-Awaited Final Guidance on Mobile Medical Applications

Sheppard Mullin Richter & Hampton LLP on

On September 23, 2013, the U.S. Food and Drug Administration (the “FDA” or the “Agency”) issued long-awaited final guidance for developers of mobile medical or health applications (or “mobile medical apps”) used on...more

Mintz - Health Care Viewpoints

FDA Issues Final Mobile Medical App Guidance

Mintz - Health Care Viewpoints on

The U.S. Food and Drug Administration (FDA) has issued long-awaited final guidance for developers of mobile medical apps. The final guidance comes more than two years after the FDA published its draft guidance in July 2011. ...more

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