FDLI’s 2026 annual conference covered several industry hot topics, with a particular focus on AI and how the FDA is leveraging technology and existing resources to improve efficiency and engage with industry. Although progress appears to be on the horizon, industry should remain mindful of the FDA’s current structural limitations and the ongoing need for human oversight of AI-driven technologies.

Modernization Across Industry and the FDA: AI, Manufacturing, and Policy Priorities

A panel discussion titled “FDA Today: Milestones, Modernization, and MAHA” emphasized several parallel priorities relative to AI and the focus on domestic manufacturing. With respect to AI, FDA leadership suggested that the Agency is using such tools in conjunction with real-world data to inform regulatory decision-making. Technology is also being used more broadly to enhance evaluation of quality systems and inform priorities for oversight activities. Following the current administration’s priorities, it appeared that there will be an ongoing focus on strengthening U.S.-based manufacturing as well as continued discussions relating to the future of funding from user fees. At the same time, questions around funding, workforce capabilities, and congressional oversight remain central to sustaining the U.S. innovation model, particularly in areas under FDA oversight.

Wearables and Wellness Technology: A Shifting Regulatory Boundary

One of the sessions highlighted wearable technologies, reflecting their role in healthcare and consumer wellness as well as being a priority to the current administration. In January 2026, the FDA issued a guidance document titled General Wellness: Policy for Low Risk Devices in order “to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health’s (CDRH’s) compliance policy for low-risk products that promote a healthy lifestyle.” Key themes contained in this guidance, as well as the breakout session related to this topic, include that the FDA’s evaluation of wearables increasingly hinges on how products are labeled and marketed rather than solely on their inherent functionality. Various speakers suggested that companies can generally remain within wellness guidance by avoiding claims tied to specific diseases or conditions while still encouraging users to seek medical advice. The session also highlighted that the incorporation of AI into wearables could significantly expand their capabilities while also potentially introducing regulatory complexity and the potential to move beyond the frameworks of the 2026 guidance. This evolving landscape underscores the criticality of carefully structuring product claims and monitoring how technological enhancements may shift regulatory classification.

How the FDA Is Using AI: Infrastructure, Use Cases, and Limitations

Several sessions provided insight into the FDA’s internal AI strategy and implementation:

  • Data Infrastructure: The FDA signaled that it is developing a unified, secure data platform (referred to as “Halo”) to support AI tools like “Elsa,” with the goal of reducing barriers between data and analytics.
  • FOIA and Administrative Processes: Speakers during the conference noted that AI is being piloted for tasks such as redacting sensitive information in Freedom of Information Act (FOIA) responses. While efficient, these tools currently require significant human oversight due to accuracy limitations.
  • Human Oversight Remains Critical: The FDA speakers consistently emphasized a “human-in-the-loop” approach. AI should be treated as an assistive tool rather than a decision-maker, particularly given its variability in performance across use cases. In addition, the speakers suggested that there is no “one size fits all approach” and that understanding the use case is critical to understanding the appropriate use of AI.
  • Data and Trust Considerations: Concerns around intellectual property, data validation, and training sources remain top of mind for industry; however, the FDA noted that sponsor data is not being used to train its AI systems.
  • Future Applications: While current use cases are relatively limited, there is potential for AI to support more complex regulatory decisions (e.g., toxicology assessments) provided that sufficient and clear documentation exists.

The take-home message, as summarized by Sridhar Mantha, the FDA’s Acting Chief Information Officer, Office of Digital Transformation, is that “AI is an assistant at FDA, but it is not a decision maker.”

Inspections Reimagined: Risk-Based and Globally Coordinated

The FDA’s inspection model continues to evolve in response to global supply chains and technological advancements. AI is being used to help identify higher-risk products and facilities, enabling more targeted inspections rather than reducing overall inspection volume. Elizabeth Miller, the Associate Commissioner for Inspections and Investigations in the FDA’s Office of Inspections and Investigations, highlighted some key areas in the inspection landscape, including:

  • Expanded Global Inspections: The FDA has increased unannounced inspections abroad, including in India and China, with plans for broader expansion while also emphasizing that domestic and foreign inspections should meet the same bar.
  • One-Day Inspection Pilot and PreCheck Pilot Program: Early results indicate that a one-day approach to inspections can be effective for low-risk facilities with strong compliance histories. Likewise, the PreCheck Program is intended to create pathways in which industry can engage with regulators earlier in the development lifecycle.
  • Remote Records Requests: Miller emphasized that remote requests should be treated with the same rigor as on-site inspections, noting that inadequate responses have led to enforcement actions.
  • Global Agency Coordination: Efforts are underway to strengthen collaboration with other global authorities and improve data-sharing systems.

Despite the improvements noted above, variability between FDA Centers and field investigators can present challenges, reinforcing the importance of maintaining inspection readiness and strong quality systems.

Key Takeaways for Industry

Several overarching themes emerged from the conference:

  • AI adoption is accelerating but continues to be measured. The FDA is investing in AI capabilities, but current applications remain a work-in-progress and require human oversight.
  • Regulatory expectations are evolving. From clinical trial design to wearable technologies, companies should remain abreast of shifting guidance and enforcement priorities.
  • Transparency and engagement are critical. Early and proactive engagement with regulators, including through pilot programs and pre-submission pathways, can support smoother development and compliance processes.

As the FDA continues to modernize, collaboration between the Agency and industry is essential. It will be important for industry to monitor how the Agency evolves amid leadership changes and whether these core themes persist over the coming year.