FDA Digital Health Advisory Committee overview:
- Who: The U.S. Food and Drug Administration is establishing a new Digital Health Advisory Committee.
- Why: The FDA committee will explore the scientific and technical issues related to rapidly-developing digital health technologies.
- Where: The FDA is an agency within the U.S. Department of Health and Human Services.
The U.S. Food and Drug Administration has established a new Digital Health Advisory Committee that will look into the complex scientific and technical issues related to technologies such as artificial intelligence and machine learning, augmented reality, digital therapeutics, remote patient monitoring, virtual reality, and wearables, according to an Oct. 11 FDA news release.
The FDA Digital Health Advisory Committee is expected to be fully operational in 2024 and will advise the FDA about issues related to rapidly developing digital health technologies to help the agency better understand the risks, benefits and clinical outcomes associated with their use.
FDA committee will include members with expertise from diverse disciplines, backgrounds
The FDA committee will include individuals with scientific and technical expertise from diverse disciplines and backgrounds. There will be nine voting members including the chair, plus a varying number of temporary members who will be selected for particular meeting topics.
“As one of our strategic priorities, our goal is to advance health equity in part through expanding access by bringing prevention, wellness and healthcare to all people where they live — at home, at work, in big cities and rural communities,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
“Digital health technologies are critical for achieving this transformation in care delivery,” Shuren continued. “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.”
The FDA is an agency within the U.S Department of Health and Human Services. It is responsible for protecting public health by ensuring the safety and effectiveness of drugs, vaccines and medical devices, as well as the safety and security of the nation’s food supply, dietary supplements and cosmetics.
The FDA recently announced updated draft guidelines for food manufacturers regarding hazard analysis and risk-based preventive controls for human food.
What do you think about the FDA’s establishment of a Digital Health Advisory Committee? Join the discussion in the comments.
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