FDA Unveils Upgrades for the Agency’s Elsa AI Agent

The FDA’s May 6 press release states that Elsa 4.0 represents a significant upgrade to the AI tool, streamlining several ordinary functions in a manner that reduces FDA staff time on these functions. Elsa 1.0 went live in June 2025, providing workflow support and summaries of documents such as premarket submissions. The agency has rapidly iterated the algorithm in the intervening 11 months to add features such as voice-to-text dictation, document format conversion and optimized search capabilities allowing agency staff to locate key information in the large repository of documents in the FDA database.

Along with the upgrade of Elsa to version 4.0, the FDA stated that it has consolidated more than 40 application and submission data sources from all FDA product centers that will amplify the utility of Elsa 4.0. This new system, known as the Harmonized AI & Lifecycle Operations for Data (HALO) platform, is integrated with Elsa 4.0 to facilitate routine operations and eliminates the need to manually upload documents into Elsa.

Marty Makary, at the time the FDA’s commissioner, stated that these two developments both allow FDA staff to “focus more on science” and make staff workstreams “more efficient and enjoyable.” Jeremy Walsh, the agency’s chief AI officer, said FDA staff previously had to direct Elsa to the location of data before Elsa could execute a query, but that now Elsa “sits on top of our data.” The announcement is mum on the question of how Elsa 4.0 and HALO will assist the agency in its management of its inspectional activities, however.

The May 6 announcement for the release of Elsa 4.0 coincided with the announcement that the FDA is piloting a one-day inspection program designed to make the agency’s inspectional processes more important. The pilot program had launched on an unspecified date in April 2026, by the end of which the agency had conducted 46 of these one-day assessments.

The FDA inspections database provides an end date for inspections but no start date, making it difficult to identify which inspections were conducted under this one-day pilot. The FDA’s Center for Devices and Radiological Health participates in the Medical Device Single Audit Program (MDSAP), which substitutes for routine surveillance inspections of device manufacturing sites. However, these inspections cannot be used as substitutes for pre-approval or for-cause inspections.

While there appear to be no drug manufacturing inspection programs coordinated by the International Council for Harmonization, the FDA has issued guidance for non-traditional inspection tools. The September 2025 guidance for inspections of drug and biologics facilities for pending applications allows the use of alternatives to traditional pre-approval inspections.

The FDA single-day assessment program is to be applied across all product centers, and the investigator can expand the scope and/or duration of the assessment should circumstances warrant. The agency emphasized that this approach will not be applied to facilities manufacturing complex products or facilities deemed at high risk. A high-risk facility typically is one with a recent inspectional outcome earning a voluntary action indicated or official action indicated outcome.

This single-day inspection program complements the agency’s use of remote regulatory assessments and other non-traditional inspection mechanisms. Elizabeth Miller, the associate FDA commissioner for inspections and investigations, said the agency will scrutinize the data to evaluate how these single-day audits can complement each product center’s broader inspectional strategy. This pilot program will continue throughout fiscal year 2026, although the agency did not rule out continuing the program into fiscal 2027, which begins Oct. 1, 2026.