MobiHealthNews: FDA establishes Digital Health Center of Excellence

“The FDA announced today the launch of the Digital Health Center of Excellence, a central resource intended to help the agency as well as external stakeholders promote digital health technologies.”

“Housed within the Center for Devices and Radiological Health (CDRH), the Digital Health Center of Excellence (DHCE) will focus on a range of technologies ‘mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products,’ the agency said. It will be headed by Bakul Patel, who until now has served as director of the CDRH’s Division of Digital Health…”


The FDA has a broad range of goals for the DHCE. The center is intended to help the agency reimagine digital health oversight, advance best practices within the industry, provide technological advice when needed and generally serve as the quarterback for digital health-focused initiatives within the agency.”

“But the FDA also admitted that its newest center is still very much a work in progress, noting that ‘there are many aspects of the [DHCE] that are still under development.’ On that front, the agency said that the DHCE will be building a network of digital health experts and organizing opportunities for stakeholders to share their digital health concerns, experiences and priorities through ongoing forums known as Collaborative Communities. From there, the center aims to launch strategic digital health initiatives and strategic partnerships that can inform its work and fuel regulatory science research for digital health technologies.”

“Of note, the DHCE has also put out a call for software engineers, artificial intelligence and machine learning engineers, security researchers, designers and product managers to join its ranks…” Read the full article here.

Source: FDA establishes Digital Health Center of Excellence – By Dave Muoio, September 22, 2020. MobiHealthNews.



Please enter your comment!
Please enter your name here