The United States Department of Health and Human Services announced a major restructuring at the Food and Drug Administration on September 8, 2026, creating a dedicated leadership role for artificial intelligence. Jared Seehafer, M.S. has been appointed as the FDA's inaugural Deputy Commissioner for Technology and Artificial Intelligence, bringing approximately two decades of experience at the intersection of software, artificial intelligence, and regulated medical technology.
The administrative overhaul places technology and automated systems at the center of the agency's senior leadership hierarchy. Alongside Seehafer's appointment, HHS announced three additional senior selections to lead vital agency centers, signaling a deliberate administrative push to modernize federal regulatory frameworks, accelerate medical innovation, and address complex public health challenges.
Establishing the Deputy Commissioner for Technology and Artificial Intelligence
As the agency's newly designated senior leader for software, technology, and AI, Seehafer will be tasked with formulating an agency-wide strategy governing how advanced digital systems are integrated into federal oversight. The newly formed position reflects the administration's stated commitment to modernizing federal technology while establishing rigorous regulatory standards for emerging tools. Seehafer's two decades of professional experience position him to navigate the technical complexities inherent in evaluating software-driven medical products.
The creation of this office formalizes the agency's growing engagement with automated systems. As artificial intelligence becomes increasingly pervasive across pharmaceutical development and medical device engineering, regulators face mounting pressure to establish clear compliance pathways. The FDA previously issued draft guidance in May 2026 addressing the use of artificial intelligence to generate data supporting regulatory submissions for drugs and biological products.
Navigating Regulatory Challenges of AI-Generated Evidence
The integration of artificial intelligence into healthcare presents distinct regulatory hurdles, most notably concerning the reliability and verifiability of automated outputs. The FDA must determine whether AI-generated or AI-assisted evidence meets rigorous evidentiary standards required to substantiate the safety and effectiveness of pharmaceutical products and biological therapeutics. Ensuring data quality, transparency, and validation remains a central operational mandate for the agency.
While advocates point to artificial intelligence as a mechanism to process massive volumes of clinical-trial data, identify safety signals, and streamline regulatory reviews, supervisory challenges persist. Regulators must understand the underlying algorithms and reasoning paths utilized by automated systems before relying on them for critical decisions affecting patient safety. This reality ensures that human supervision, algorithmic transparency, and rigorous validation protocols will remain foundational to federal oversight.
Comprehensive Leadership Restructuring Across FDA Centers
In addition to the technology appointment, HHS named permanent directors for three key FDA operating centers, formalizing transitions from previous acting leadership. Dr. Michael Davis, M.D., Ph.D., was selected as Director of the Center for Drug Evaluation and Research after serving as acting director and deputy center director. Davis brings extensive clinical and regulatory experience to CDER, where his agenda will focus on increasing patient access to safe medicines, advancing evaluation science, and strengthening the pharmaceutical supply chain.
Concurrently, Karim Mikhail, B.Pharm, MSc, was named Director of the Center for Biologics Evaluation and Research. Mikhail brings decades of experience spanning the biotechnology sector and the FDA, focusing on modernizing regulatory frameworks for cellular and gene therapies, vaccines, and blood products while strengthening vaccine safety surveillance. Additionally, Dr. Bret Koplow, Ph.D., J.D., was appointed Director of the Center for Tobacco Products after serving as senior counselor to the commissioner.
Administrative Mandates and Modernization Goals
The broader administrative strategy underpinning these selections aims to build institutional infrastructure capable of handling advanced medical technologies while accelerating product reviews. HHS Secretary Robert F. Kennedy Jr. emphasized the reform agenda in a public statement regarding the appointments. “We are building an FDA that moves faster, demands excellence, and delivers results for the American people,” Secretary Kennedy said, adding that the newly appointed leaders will confront serious health challenges and strengthen American innovation.
Echoing these priorities, FDA Acting Commissioner Kyle Diamantas, J.D., noted that the selections are designed to attract best-in-class talent and construct the workforce necessary to support innovative work across all agency centers. “These selections are not just about filling leadership roles — they signal the direction we are heading,” Diamantas said, emphasizing that the incoming leadership will help build infrastructure across all divisions.
Implementation Timelines and Regulatory Milestones
The newly constituted leadership team assumes office immediately, taking charge of ongoing pilot programs exploring cloud-based and automated approaches to clinical trials, particularly within early-phase evaluations. The agency's ongoing implementation of its May 2026 draft guidance on AI-generated data will serve as an early test for Seehafer's newly established office. Regulatory stakeholders await further administrative announcements regarding how the newly minted technology division will interact with established drug evaluation centers during upcoming product review cycles.
