FDA launches digital health center of excellence
A new digital health Center of Excellence within the US Food and Drug Administration (FDA) aims to boost digital health innovation by fostering partnerships and connections among digital health stakeholders.The DHCoE’s website details services offered, including examples of CDRH-specific, FDA-wide and external efforts to “translate digital advances into tools that benefit consumers.”
The Center is housed within FDA’s Center for Devices and Radiological Health (CDRH), and forms part of CDRH’s larger digital health strategy. “A key benefit of the Digital Health Center of Excellence is that it will support and encourage developers—including those who are new to the health care space—to translate digital advances into tools that benefit patients and consumers,” said FDA in announcing the launch of the new Digital Health Center of Excellence (DHCoE).
Among the other offerings within the DHCoE is a Network of Experts that has now been formalized into a “permanent, specialized pool of expertise.” These experts, explains FDA, are members of partner organizations who have been required to provide conflict of interest forms and disclose any other issues that might affect their ability to provide impartial advice and information. The expert pool is available for consultation to CDRH staff in such topic areas as artificial intelligence, wearables, digital therapeutics, real-world evidence, cybersecurity and more.
Individuals who currently are members of the 100+ partner organizations for the Network of Experts and wish to join the program may contact FDA with a recent curriculum vitae, home organization and area of expertise.
The expert pool, said FDA, may be tapped for such areas as pre- and postmarket issues, clinical care and new and evolving developments in digital health.
Also housed within the DHCoE are resources for developers of software as a medical device (SaMD). The website provides a portal for developers to ask questions and provides links for public input and SaMD guidance.
Mobile medical applications, wireless medical devices, and the new digital health software precertification (Pre-Cert) program all have dedicated webpages and resources within the DHCoE as well. (RELATED: FDA updates Pre-Cert pilot for SaMD, Regulatory Focus 14 September 2020)
Stakeholder listening sessions held by FDA in October and November will provide a forum for those interested to learn about the scope of the new Center and to ask questions.
FDA