ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA pursues aggressive plan to adopt AI tools to streamline reviews; the agency outlines its deregulation plan; CMS requests input on digital health apps for Medicare; medtech reimbursement bills resurface; South Korea and Hong Kong device guides; Brazil consultation; AI Act grandfathering; tariff testimony; and more.
FDA Picks
AI review tools; Deregulation—what it is, and what it isn’t:
[Editor’s note: The brief below was updated May 15 with comments Commissioner Makary made during FDLI’s annual meeting that day in Washington DD.]
FDA AI review tools. FDA is pursuing an “aggressive” rollout of artificial intelligence to assist premarket review, the agency’s Commissioner Marty Makary announced May 8. Makary is pressing all of FDA’s centers to immediately begin deploying recently piloted AI tools to support scientific review and to fully integrate the technology by the end of June. The effort will be coordinated by Jeffrey Walsh, FDA’s newly appointed chief AI and IT officer, and Sridhar Mantha, who was most recently an IT official in the agency’s drug center. “I was blown away by the success of our first AI-assisted scientific review pilot,” Makary said in a press release. “We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process.” During a May 15 appearance at the Food and Drug Law Institute annual meeting in Washington DC, Makary suggested the agency was primarily looking to AI to summarize vast troves of documents that come in with premarket submissions. “Sometimes thousands of pages come in the background and preliminary data of an application, and some of it is repetitive,” Makary said. “The AI is summarizing it for our scientific reviewer.” The commissioner said he met with the reviewer that conducted the first AI-assisted review under the recent pilot last week. “The reviewer said AI did in six minutes what it would normally take him two-to-three days to do,” Makary noted.
AI to clear 510(k)s? Individual centers within the agency have already been employing AI to help streamline some tasks, including detecting fraud in applications. According to one former CDRH official who left FDA this year and spoke to Market Pathways on the condition of anonymity, the device center had been working on a yet-to-be-launched initiative where AI would screen through pending 510(k) submissions and identify applications that can be quickly cleared, allowing reviewers to prioritize their focus on more complicated submissions. “This is what could get you to a 7-10 day 510(k) for normal submissions,” said the former official. CDRH was developing this AI review method prior to President Trump taking office and Makary coming on as commissioner. It is not clear whether it is part of the current rollout.
