On 22 September 2020, The U.S. Food and Drug Administration has made announcements with regards to the launching of the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The agency is aiming to further its overarching dedication focused on the advancement of digital health technology, comprising of wearable when used as a medical device, mobile health devices, and technologies used to study medical products. The launching of the Digital Health Center of Excellence is an important step towards achieving the objective.
As part of an initiative to modernize regulatory approaches and digital health policies, the FDA will continue to construct and formalize the coordinating structure and operation of the Digital Health Center of Excellence. This effort will also expedite access to effective and safe digital health technology as well as specialized expertise.
The function of Digital Health Center of Excellence is to assist internal and external stakeholders in providing high-quality digital health technologies to patients by giving technological advice, coordinating, and supporting work being done across the FDA. The other functions include reimagining digital health device oversight and advancing best practices.
The FDA staff will be able to access the network of digital health experts and engage in knowledge sharing concerning digital health issues through Collaborative Communities.
Among an integral part of the launch are activities such as launching of strategic initiatives to advance digital health technologies, facilitation of synergies in regulatory science research in digital health, and building strategic partnerships.
The Digital Health Center of Excellence is committed to further the advancement of science and evidence for digital health technology within the regulatory framework of FDA.
The ultimate objective is to facilitate the empowerment of digital health stakeholders to advance healthcare through effective, safe, and high-quality digital health innovation.
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