The Food and Drug Administration is taking a closer look at digital health tools — and the way they are regulated. The agency announced on Tuesday that it had created the Digital Health Center of Excellence, tasked with providing expertise to help accelerate access to safe and effective digital health tools.
Bakul Patel, who had been leading regulatory efforts related to digital health at the FDA since 2010, will head up the new center. He was previously director of the Center for Devices and Radiological Health’s (CDRH) digital health division, where he helped create its software precertification pilot program, which would to allow digital health companies with tested quality assurance protocols to update their products faster.
The FDA said the new Digital Health Center of Excellence will be tasked with providing technical advice, advancing best practices and “reimagining digital health device oversight.” The agency is also building a group of digital health experts that can share their knowledge with FDA staff.
“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,” CDRH Director Dr. Jeff Shuren said in a news release. “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 FDA has also taken steps to broaden access to digital health tools since the start of the Covid-19 pandemic. For instance, the agency temporarily waived some restrictions around the use of behavioral health software tools, allowing low-risk digital health products to be distributed to the public without a 510(k) premarket notification. But they still had to meet some quality measures, including software verification and cybersecurity requirements.
The agency has also allowed for expanded use of remote monitoring devices during the pandemic, though companies must distinguish which indications have been FDA cleared.
Source: FDA, Flickr
