FDA https://www.fda.gov has launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The Center will advance digital health technology to include mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and use technologies to study medical products.
FDA is going to use the Center 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 effective digital health technology. The agency is appointing Bakul Patel as the First Director where he has been leading regulatory and scientific efforts related to digital health devices at FDA since 2010.
“The establishment of the Center is part of FDA’s plan to amplify the digital health work that is already being done and building upon years of work at the agency,” said Jeff Shuren M.D., J.D., Director of CDRH.
He also reports, “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 our regulatory approaches.”
The work of the Center is going to create a network of digital health experts to share knowledge and experience concerning digital health issues and priorities with FDA staff. Activities will be provided to advance digital health technologies, facilitate synergies in regulatory science, research in digital health, and facilitate and build strategic partnerships.
Go to https://fda.gov/medical-devices/digital-health-center-excellence for more information on the FDA Digital Health Center of Excellence.