FDA’s Elsa at Eleven Months: AI-Powered Operations and One-Day Inspections Signal a New Oversight Paradigm

Recent United States Food and Drug Administration (FDA) announcements continue to highlight the agency’s increasing development and use of artificial intelligence. Earlier this month, FDA announced the launch of the latest version of Elsa – the internal AI solution it first announced last June. That same day, speaking at the Food and Drug Law Institute (FDLI) annual conference, the FDA Commissioner at the time, Dr. Martin Makary, announced a new pilot program for “one-day inspections” driven by AI-backed risk analysis for low-risk facilities. Taken together, and against the backdrop of Elsa’s launch less than a year ago, these developments show a continued push from FDA to leverage AI to expedite its operations, including in the enforcement space – a push that could have direct consequences for regulated entities across FDA product categories.

Increased AI Capability and Integration at FDA

Far from backing off its commitment to AI deployment and integration, FDA is showing its dedication with new developments for its AI platform, Elsa. Less than 11 months after its initial launch, FDA announced the release of Elsa 4.0 alongside Elsa’s integration with a new unified platform, HALO (Harmonized AI & Lifecycle Operations for Data), which consolidates 40 disparate application and submission data sources, systems, and portals. FDA says this integration will let staff query data and build workflows without having to manually upload documents within each chat session. As Chief AI Officer Jeremy Walsh described this shift, “Previously, FDA staff would bring data to Elsa. Now, Elsa sits on top of our data.” This announcement follows testimony last month from Secretary of Health and Human Services Robert F. Kennedy Jr. that more than 90% of reviewers at FDA are now using AI to accelerate drug approvals. New Elsa 4.0 capabilities include custom AI agents, document generation, quantitative data analysis and visualization, secure web search, voice-to-text dictation, optical character recognition for scanned documents, improved chat capabilities, and optimized search capabilities across large document repositories.

Yet, FDA’s announcement closes with a reminder that FDA staff are in the loop “at every stage of the AI work process in Elsa” and that inputs, analytic processes, and output implementation are all verified. The announcement also emphasizes that the AI model does not train on “any data submitted by regulated industry” and does not access “the sensitive research and data handled by FDA staff.”

One-Day Inspections and AI Risk Analysis

At the FDLI annual conference, then-Commissioner Makary also announced FDA was piloting a one-day inspection program, which is designed to make inspections more efficient for select entities. The one-day inspections are intended to expedite the inspection process for what the agency regards as “low risk facilities” and are shorter screening assessments than standard inspections, which the one-day inspections are intended to supplement rather than replace. FDA is employing the inspections across product categories and clinical research programs, according to a related press release. The risk-based criteria used to identify the facilities reportedly include product types, prior inspectional history, and operational characteristics.

Facilities identified as low risk by AI are candidates for these shorter inspections, though FDA has noted that inspectors conducting these inspections maintain the ability to expand the scope and length of an inspection once on site. The pilot, which launched in April 2026, has already completed over 40 assessments, and most of the one-day inspections conducted thus far have resulted in No Action Indicated (NAI) classifications. Still, Associate Commissioner for Inspections and Investigations Elizabeth Miller, speaking at FDLI, noted that these abbreviated inspections can result in FDA Form 483 observations.

FDA intends to leverage data from these inspections to refine its risk-based approach for oversight activities, noting that “recurring compliance themes, facility specific risk scores, and discrepancies between registered and actual operations” may help direct future oversight. Given the emphasis on risk profile, some operations (such as sterile injectables) are unlikely candidates for one-day inspections. But even sites with exemplary inspection histories and low-risk operations should remain prepared for full-scope inspections. Given that investigators retain the ability to expand the scope and duration of an inspection, sites should not expect or rely on these screening inspections to be the full extent of FDA oversight. Being prepared to speak to every aspect of operations is critical to ensuring a positive inspection outcome, particularly where expedited timelines may reduce the ability for sites to gather information in the midst of an inspection – making sure materials typically requested during inspections are ready to deliver quickly, for example, may help qualifying sites keep such inspections from expanding.

Key Takeaways

• FDA isn’t letting Elsa go. Less than a year after its rollout, FDA continues to leverage AI in its operations and is continually expanding Elsa’s functionality. While FDA staff remains in the loop, Elsa’s continued growth shows an appetite for modernization and highlights the agency’s goal of increasing efficiency. Time will tell how useful the new Elsa 4.0 features will be and how adept FDA’s staff become.
• Complex operations and high-risk products are not candidates for one-day inspections. FDA has been clear that eligibility for such inspections is informed by a risk-based analysis to expedite oversight of low-risk operations. Higher risk sites with complex operations or products, such as implantable devices and sterile manufacturing, will likely remain subject to the normal inspection approach by FDA.
• One-day assessments raise the bar for readiness on day one. FDA indicated that facilities will not be advised whether they are part of the pilot program. As such, sites should be prepared for both limited and full-scope inspections. Being able to quickly pull and deliver requested information may help ensure that a one-day inspection assessment does not expand in scope or duration – and if it does, the site would still benefit from the normal level of robust preparation.

This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.