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K&L Gates LLP

FDA's Evolving Policy Toward Health IT, Medical Apps, and Low Risk Devices

K&L Gates LLP on

Between January 20 and February 9, 2015, the U.S. Food and Drug Administration (“FDA”) issued four guidances related to its policies toward low risk devices. These guidances were largely developed as an outgrowth from FDA’s...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Guidance for Mobile Medical Applications: What Will be Subject to FDA Oversight and Enforcement?

Sheppard Mullin Richter & Hampton LLP on

On February 09, 2015, the FDA issued final guidelines[1] to outline its regulatory enforcement approach to mobile medical applications (or “apps”). The FDA is taking a risk-based approach, focusing its oversight on apps that...more

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