FDA to form advisory committee for digital health and AI

ANAHEIM, California—As more and more medical technologies are being built on artificial intelligence and machine learning, the FDA is enlisting a new panel of outside experts to help it get deeper into the weeds.

The agency announced plans to launch a new advisory committee next year focused on digital health including not just AI but also therapeutic apps and software, wearable devices, remote patient monitoring programs and virtual and augmented reality tools.

“We’re in a very interesting time. I joined FDA about nine months ago, and one of the things that was really attractive to me is this desire to start working with the industry much closer around addressing some of the big health needs,” Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence, said during an agency town hall at the AdvaMed MedTech Conference. 

“In order to be able to do that, we have to start aligning. It can't be an effectively transactional relationship, and opportunities like advisory communities provide that ongoing dialogue that’s needed to say, ‘What is our shared objective?’” Tazbaz said.

The new committee will stand alongside the FDA’s roster of other advisory panels, such as those focused on investigational cancer drugs and cutting-edge cell and gene therapies.

But while product-specific questions will remain within those dedicated meetings, the Digital Health Advisory Committee will focus in part on offering counsel to the FDA and its leadership on cross-cutting technical and scientific issues as well as how those issues could interact with the agency’s policies and regulatory proposals or even lead to unintended consequences.

“If you write a guidance that the industry doesn’t know what to do with it, it’s just a piece of paper at that point,” Tazbaz said.

The FDA previously launched a digital-health-focused center of excellence in late 2020 to serve as a coordinating hub for oversight within the Center for Devices and Radiological Health (CDRH), as well as to provide subject matter expertise to the agency as a whole. Since then, it has also reorganized its internal health IT, data management and cybersecurity under a single Office of Digital Transformation that reports to the commissioner.

The new committee will not be beholden to the FDA’s device-focused center; its work will span the agency and tap into broader issues such as decentralized clinical trial designs, patient-generated health data and product cybersecurity.

The digital health committee is slated to have nine core members, with the addition of temporary, specialized members on a topic-by-topic basis. The agency is currently collecting nominations for panelists and said it aims to hold its first meeting in 2024.

But before it gavels in, the FDA plans to put out new guidance documents around AI and machine-learning-enabled products before the end of this calendar year, according to the FDA’s device center director, Jeff Shuren, M.D.

That includes finalizing guidance published earlier this year on change control plans, which would allow devices to be iteratively improved as they collect more data. Other plans include new draft guidances on premarket submission recommendations for AI services and on considerations for product lifecycle management.

Shuren also alluded to ongoing changes in how the agency’s advisory committees operate. 

“The agency is, I think, moving away from the mindset of even holding a vote on a product,” he said. “We don't typically do that [in CDRH]. We have targeted questions, we get that feedback—because at the end of the day, that decision is a combination of science and the law on the regulatory side, and ultimately it falls to us. And sometimes the votes really don't reflect that full consideration.” 

“The individual perspectives from each of the members is very rich, and we use that,” Shuren continued. “And that approach is bleeding now into other medical products, and I think you'll see a bit of that shift elsewhere in the agency over time.”