Dive Brief:
- The Food and Drug Administration is establishing a digital health advisory committee to improve its understanding of the benefits, risks and clinical outcomes of the technologies, the agency said on Wednesday.
- The committee will consist of nine voting members including the committee chair. Members will be selected by the FDA commissioner or a knowledgeable designee.
- “We want to ensure that we're working with industry and listening to the industry, but also focusing on some common objectives to ensure that our ultimate goal is to improve public health, and as part of the ecosystem, we have to do that together,” Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence, said at The MedTech Conference on Wednesday.
Dive Insight:
The FDA is looking for input from technical and scientific experts as it grapples with how to regulate new technologies, including machine learning tools, virtual reality and wearables. The agency also said it is considering issues around decentralized clinical trials, patient generated health data and cybersecurity.
The goal of the committee is to help the FDA better understand these devices, and any “risks, barriers or unintended consequences” that could result from FDA policy, the agency said in its announcement.
Tazbaz, who joined the FDA in late January, said that part of the reason he was interested in the job was the agency’s desire to work with industry on addressing public health needs.
“In order to be able to do that, we have to start to align. It can’t be an effectively transactional relationship,” Tazbaz said. “Opportunities like advisory committees provide the ongoing dialogue that is needed to say, what is our shared objective?”
The FDA said in its announcement that it is looking for experts from diverse disciplines and backgrounds. It is accepting applications until Dec. 11.
