AI Summit panelists forecast FDA regulatory climate in second Trump administration

Evolving regulatory paradigms governing AI use in health care at the U.S. Food and Drug Administration (FDA) have set the pace for AI regulatory frameworks worldwide. Jodi Scott, partner in the Hogan Lovells medical device & technology regulatory practice, teed up a panel conversation at the AI Health Law & Policy Summit over evolving regulatory standards for AI by providing background on how the U.S. has been a pioneer in crafting innovative and comprehensive AI regulations.

Yarmela Pavlovic, Chief Regulatory Officer at Medtronic, provided additional background on how FDA has served as a “learning laboratory” for the world, with the successes of its AI regulatory frameworks being repeated in other governmental bodies. Indeed, “it has been a big priority for FDA to be involved in this space,” said Quentin Moore, Ph.D., former FDA lead product reviewer and current Director of Regulatory Affairs at Aidoc. Dr. Moore observed how FDA is continuing to work to harmonize global AI regulations. 

Kyrsten Sinema, former U.S. Senator and senior advisor at Hogan Lovells, said that about half of her practice now revolves around AI, expressing optimism over its surging implementation in health care. Asked about how the Trump administration started this term by temporarily withdrawing from many international bodies, Sen. Sinema remarked that there is “little to extrapolate” from the withdrawal regarding FDA’s AI policy. 

“I do not think this administration will be one of isolationism,” Sen. Sinema predicted, citing how newly-minted FDA Commissioner Marty Makary is a data scientist who “will go where the data leads rather than follow the herd.” Sen. Sinema predicted: “It might look different, but I think you’ll see the U.S. continue to lead.”

Considering if and when the dust may settle on the Trump administration’s policies, Sen. Sinema forecast that the current “disruptive” state of affairs may continue for the next four years. Sen. Sinema expressed enthusiasm over the current administration’s openness to change, predicting that the new regulatory climate – coupled with Makary’s prioritization of data –presents opportunities for sponsors of new technologies. She speculated there will also be an interest in speeding up the regulatory approval process for products that have good data, and in providing access to consumers earlier, even to products that may still be undergoing FDA review. “The industry needs to accept the idea that that which has never occurred is now more likely to happen,” Sen. Sinema said. Scott agreed that there are opportunities emanating from the new administration’s disruptive activities. 

Although she anticipated the regulatory disruption will be “ongoing” in the Trump administration, Sen. Sinema predicted the DOGE layoffs are a one-time “shock-and-awe” event, with FDA layoffs anticipated to wind down. Nevertheless, FDA device review teams are “very small,” and the absence of even singular reviewers “will be noted,” Dr. Moore said. Reviewers in FDA’s Center for Devices and Radiological Health (CDRH) do not miss deadlines, he said, recalling how they worked long hours at FDA to ensure products would come to market in a timely fashion. Therefore, Dr. Moore concluded, the layoffs of FDA reviewers were effectively “shocking” to the system. Working through the disruption at FDA will be challenging, but device review teams are “left intact,” and their work can remain prioritized, Dr. Moore observed. 

Regarding device marketing submissions, Dr. Moore observed an uptick in AI-enabled medical device applications, predicting FDA will need to hire more experts in AI. However, with many of the recent FDA hires being in the field of AI were still on probation, many of those government employees have chosen to leave the agency, “and AI workers are in high demand,” he said.

FDA’s Digital Health Center of Excellence was not affected by the DOGE layoffs, Dr. Moore noted, citing how the predetermined change control plan (PCCP) guidance has been helpful to industry. From his experience at FDA, he said it accurately reflects the agency’s thinking. Scott agreed that FDA has done “great work” in the PCCP guidance, pointing out that elements of that guidance document were incorporated by the EU in their regulatory framework.

Dr. Moore predicted that regardless of what happens in the new administration, the PCCP guidance “will be followed.” He recommended that AI device sponsors plan for multiple iterations of their products in their marketing submissions, explaining that predicate testing can be used to a sponsor’s advantage. He further suggested planning for an impact assessment, as well as data recycling plans.

In concluding remarks for the panel, Sen. Sinema pointed out the new administration is taking a “whole of government” approach” to AI, expressing optimism that there will be “energy and excitement” to address the novel, emerging questions over how to best regulate AI-enabled medical devices. Indeed, Scott observed, the new Trump administration has demonstrated that promoting AI will continue to be priority for FDA.