FDA Announces Digital Health Center of Excellence

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On September 22, the U.S. Food and Drug Administration (FDA) announced the launch of its Digital Health Center of Excellence within the Center for Devices and Radiological Health. The FDA called this an important step toward its goal of advancing digital health technology, including mobile health (mHealth), health information technology, wearable devices, telehealth, and personalized medicine.

According to the FDA, “These technologies can empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional health care settings.” The Center will provide resources for digital health developers, including access to the FDA’s scientific expertise and technological and policy advice, and will also be issuing regulatory guidance.

The Center’s first webcast on October 19 will be an opportunity for digital health stakeholders to learn more about its purpose and functions.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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