FDA Announces the Launch of its Digital Health Center of Excellence

With all the attention on the 2020 elections, what may have been lost in the fray was the announcement that the FDA created the Digital Health Center of Excellence, within the Center for Devices and Radiological Health (CDRH). According to the FDA’s release, the new Center is dedicated “to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.”

So what is the mission of the Digital Health Center of Excellence? According to the FDA:

“The Digital Health Center of Excellence is primarily focused on helping both internal and external stakeholders achieve their goals of getting high quality digital health technologies to patients by providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimagining digital health device oversight. Along those lines, the Digital Health Center of Excellence is creating a network of digital health experts and engaging in Collaborative Communities to share knowledge and experience concerning digital health issues and priorities with FDA staff. An integral part of the launch includes the activities that will be provided to complement advances in digital health technology – such as launching strategic initiatives that advance digital health technologies, facilitating synergies in regulatory science research in digital health, and facilitating and building strategic partnerships.”

As COVID 19 has forced our society to become more mobile and technologically dependent, the trends of big data, AI, machine learning and mobile health to name a few are here to stay. 

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