FDA Establishes New Advisory Committee on Digital Health Technologies
WASHINGTON — The Food and Drug Administration is creating a new Digital Health Advisory Committee to help the agency assess and deal with the complex scientific and technical issues related to the burgeoning market of new digital health technologies.
These technologies include everything from artificial intelligence and machine learning to augmented reality, virtual reality, digital therapeutics, wearables and remote patient monitoring and software.
The new Digital Health Advisory Committee will advise the FDA on issues related to these technologies, providing relevant expertise and perspective to help improve the agency’s understanding of the benefits, risks and clinical outcomes associated with their use.
According to a written statement from the FDA, the committee should be fully operational in 2024.
“As one of our strategic priorities, our goal is to advance health equity in part through expanding access by bringing prevention, wellness and health care to all people where they live — at home, at work, in big cities and rural communities,” said Dr. Jeff Shuren, J.D., director of the FDA’s Center for Devices and Radiological Health.
“Digital health technologies are critical for achieving this transformation in care delivery. As digital health technologies advance, the FDA must capitalize on knowledge from inside and outside of the agency to help ensure we appropriately apply our regulatory authority in a way that protects patient health while continuing to support innovation,” Shuren said.
Digital health is a rapidly evolving, cross-cutting space that spans a wide range of technologies.
In addition to the technologies mentioned above, it also includes issues such as decentralized trials, patient-generated health data and cybersecurity.
“Technology moves at an incredible pace, and we’re excited to have a committee of experts throughout the field who can help ensure our regulation of these exciting tools maintains an appropriate pace while working within parameters of safety and effectiveness standards,” said Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence.
“Many of these technologies are novel and tend to rapidly change; it’s our duty to seek as much knowledge on them as possible as we determine and implement appropriate regulation to encourage innovation while protecting public health,” Tazbaz said.
The committee will consist of a core of nine voting members including the chair. The number of temporary members selected for a particular meeting will depend on the meeting topic.
Those interested in serving or nominating a representative to serve as a voting or non-voting member of the FDA’s Digital Health Advisory Committee, may either submit nominations electronically by accessing the FDA Advisory Committee Membership Nomination Portal or by mail.
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