CN
The US Food and Drug Administration (FDA) has launched a Digital Health Advisory Committee that is meant to bring together external experts across disciplines to address some of the bigger issues in digital health, including product interoperability and the effective use of artificial intelligence/ machine learning (AI/ML).
Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), announced the creation of the new Digital Health Advisory Committee at the 2023 MedTech Conference. While typically, FDA advisory committees offer external expert opinion to specific product centers, especially when the agency is considering approving a controversial product, he says the new committee will offer advice across its product centers.
"We're always looking to get outside expertise in what we do,” Shuren said during a CDRH town hall discussion on 11 October. “We're never going to have everything we need inside CDRH, it makes no sense. We want to touch talent that's outside.”
The medtech center director said that while digital health product-specific issues will remain in the purview of their respective advisory committees at CDRH, cross-cutting issues that affect multiple product centers will be addressed by the new panel. “[CDRH is] establishing it, but it's not just for us, it's for the entire agency,” Shuren said.
FDA expects the Digital Health Advisory Committee to touch on topics such as AI/ML, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software in medical products.
Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence (DHCE), which offers internal expertise on digital health technologies, said that since joining FDA from Oracle nine months ago, he’s come to realize the agency has a strong desire to work closely with medical product manufacturers to address big and emerging digital health issues.
“In order to be able to do that, we have to start to align [with industry], and it can't be effectively a transactional relationship,” he said. “Opportunities like advisory committees provide that ongoing dialogue.”
Tazbaz said the new advisory committee is part of a broader engagement strategy at FDA to listen and work with industry on common objectives, with the ultimate goal of achieving better public health on issues such as interoperability and integration of products, and the use of AI/ML.
Doug Kelly, deputy center director for science at CDRH, echoed the sentiments and said the agency is typically on the same page as manufacturers, and the new panel will help both sides further improve that alignment.
“We're 95% aligned with what everybody else wants, and the question is how do we work together in the most efficient way to decrease risk, decrease cost, increase innovation,” he said.
The Digital Health Advisory Committee will consist of nine voting members, including a chairperson. Several temporary members will also be added to the panel depending on the topic at hand, according to FDA. The agency has opened its Advisory Committee Membership Nomination Portal for stakeholders to nominate members for the committee, including themselves.
During the town hall meeting, Shuren looked across the crowd of medtech stakeholders and asked if anyone in the room was interested in volunteering for a seat on the panel. “If you may be an appropriate candidate or you know someone who is, the doors are now open for nominations and are going to stay open until December 11, so please check that out,” he said.
(Source: Regulatory Affairs Professionals Society)
