What You Should Know:
– FDA launches the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH) focused on mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.
– The Digital Health Center of Excellence is part of an effort to modernize digital health policies and regulatory approaches and provide efficient access to highly specialized expertise, knowledge, and tools to accelerate access to safe and effective digital health technology.
Today, the U.S. Food and Drug Administration (FDA), today announced the launch of the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The launch of the Digital Health Center of Excellence marks an important step in furthering the agency’s overarching dedication 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.
“Establishing the Digital Health Center of Excellence is part of the FDA’s work to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S.,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s announcement marks the next stage in applying a comprehensive approach to digital health technology to realize its full potential to 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 care settings. The Digital Health Center of Excellence will provide centralized expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public, and FDA staff.”
Here are five things to know about the new Digital Health Center of Excellence:
1. The Digital Health Center of Excellence will focus primarily 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.
2. The COE will create 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.
3. The FDA will continue to build and formalize the coordinating structure and operation of the Digital Health Center of Excellence as part of an effort to modernize digital health policies and regulatory approaches and provide efficient access to highly specialized expertise, knowledge, and tools to accelerate access to safe and effective digital health technology.
4. The FDA has appointed Bakul Patel as the first director. Bakul Patel has been leading regulatory and scientific efforts related to digital health devices at the FDA since 2010.
5. The Digital Health COE plans to launch strategic initiatives that advance digital health technologies, facilitating synergies in regulatory science research in digital health, and facilitating and building strategic partnerships.
