Eye on FDA

As medical chatbots proliferate, a new Pennsylvania lawsuit highlights a developing trend of states leading health artificial intelligence (AI) enforcement efforts, while the Food and Drug Administration (FDA) appears to be on the sidelines.

On April 28, 2026, the Food and Drug Administration (FDA) unveiled two major announcements as part of its initiative to “advance the implementation of real-time clinical trials.” In conjunction with a request for information (RFI) for a proposed pilot program, the agency announced the successful initiation of two proof-of-concept real-time clinical trials (RTCTs). Taken together, the agency’s stated goal is to enable continuous trials and reduce the “hiatuses” between the phases of clinical development, ultimately improving the drug development process.

On September 30, 2025, the Food and Drug Administration (FDA) published a Request for Public Comment to obtain feedback from interested parties on current approaches to measuring and evaluating the performance of AI-enabled medical devices. Specifically, FDA is seeking feedback on best practices, methodologies and approaches for measuring and evaluating real-world performance of AI-enabled medical devices from the public.

Recently, it was reported that the U.S. Food and Drug Administration (FDA) is launching two cross-agency artificial intelligence (AI) councils. One AI council will be tasked with addressing how the agency uses AI internally and the other will focus on policy governing AI’s use in FDA-regulated products (reportedly pre-existing AI councils in various FDA divisions will continue to operate) (Politico Pro).

Yesterday, the White House’s Make America Healthy Again (MAHA) Commission, led by the Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. released its inaugural health report titled, Make Our Children Healthy Again, delivering one of the first widely anticipated deliverables from the MAHA Commission Executive Order issued earlier this year and noted in our prior alert. The 72-page assessment examines the rising rates of childhood chronic disease in the country—including obesity, heart disease and diabetes—and explores potential contributing factors. Specifically, the report identifies and focuses on four potential drivers:

In the last two weeks, the Department of Health and Human Services (HHS) has filled key artificial intelligence (AI) positions at HHS and the U.S. Food and Drug Administration (FDA). These appointments, as well as recent statements from HHS and FDA leadership, align with the Trump administration’s intention to use AI to improve regulatory efficiency at HHS and beyond.

On December 30, 2024, FDA unveiled an Idea Lab as part of its Home as a Health Care Hub initiative to reimagine how new and existing medical devices can be incorporated in a home environment.

Today FDA issued final guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI) enabled device software functions. FDA recognizes that development of AI-enabled devices is an iterative process, and PCCPs are intended to allow developers to plan for modifications, while continuing to provide a reasonable assurance of safety and effectiveness. FDA provides that a PCCP should include planned modifications, a methodology to develop, validate and implement those modifications, and an assessment of an impact of those modifications. FDA initially introduced the concept of PCCPs in a 2019 white paper, and the Food and Drug Omnibus Reform Act of 2022 created provisions regarding PCCPs. For example, a supplemental application for a device that received Pre-Market Approval (PMA) or a new 510(k) is not required for a change to a device that would otherwise require a PMA supplement or a new 510(k) if the change is consistent with a PCCP approved or cleared by FDA. This final guidance is specific to AI-enabled devices, although PCCPs may be submitted for devices other than AI-enabled devices, and FDA has issued draft guidance that applies more broadly to all devices.

In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical companies and medical device manufacturers can adopt to mitigate risks related to supply chain disruptions, cybersecurity threats and increased FDA enforcement of quality control and compliance.