The new centre will advance the mobile health devices, Software as a Medical Device (SaMD), wearables medical devices, and other digital health technologies
The US Food and Drug Administration (FDA) has launched its Digital Health Centre of Excellence within the existing Centre for Devices and Radiological Health (CDRH).
The centre is expected to support the agency’s efforts to advance the digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables medical devices, and technologies used to study medical products.
The US regulatory agency is expected to create and operate the new Digital Health Centre of Excellence to improve digital health policies and regulatory approaches.
The new centre would provide access to expertise, knowledge, and tools for safe and effective digital health technology.
FDA appoints Bakul Patel as director for Digital Health Centre of Excellence
As part of the launch, FDA has appointed Bakul Patel as the first director for Digital Health Centre of Excellence, who has been leading the FDA’s regulatory and scientific affairs related digital health devices, since 2010.
CDRH director Jeff Shuren said: “The establishment of the Digital Health Center of Excellence is part of the planned evolution of the FDA’s digital health program to amplify the digital health work that is already being done and building upon years of work at the agency.
“In the last several years, we have established partnerships internally and externally to coordinate digital health activities and to promote the consistency of regulatory policy while continuing to innovate in our regulatory approaches.”
The Digital Health Centre of Excellence is primarily focused on helping businesses in providing technological advice, supporting the FDA’s efforts in advancing digital health devices.
The new FDA division is expected to create a network of digital health experts, ensuring sharing of knowledge and experience related to digital health, and is aimed at advancing the technologies within the FDA’s framework of regulatory oversight.
FDA commissioner Stephen Hahn said: “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 US.
“Today’s announcement marks the next stage in applying a comprehensive approach to digital health technology to realise 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 centralised expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public, and FDA staff.”