The FDA held a virtual town hall on March 11th, 2026 on the Clinical Decision Support (CDS) Software guidance update, which published on January 6th, 2026 and republished on January 29, 2026. This was an eagerly awaited event to address questions on the guidance, which was reported previously creating broader opportunities for products that the FDA does not intend to regulate. Submitters were allowed to supply in writing ahead of the town hall meeting and no questions were taken live during the virtual town hall. The FDA noted that meeting materials from the town hall (recorded presentation, slide deck, transcript) will be available in the future at CDRH Learn under “Specialty Technical Topics,” sub-section “Device-Specific Topics.”
The FDA presenters for the town hall included:
- Danielle Faruq (Digital Health Specialist, Division of Digital Health Policy Office of Strategic Partnerships and Technology Innovation)
- Aneesh Deoras (Assistant Director of Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices; Office of Cardiovascular Devices; Office of Product Evaluation and Quality and Acting Division Director for Division of Digital Health Technology Assessment, Office of Strategic Partnerships and Technology Innovation)
A slide deck was presented by both FDA personnel noted above, which outlined some key points of the CDS software guidance Criterion 1 through 4. Afterwards a Q&A session was conducted and all questions were fielded by Aneesh Deoras, who is now Acting Division Director Division of Digital Health Technology Assessment. Aneesh Deoras also fielded all of the questions in the General Wellness town hall that was previously reported, so he is clearly being positioned as a primary point person at FDA regarding questions on CDS software products in addition to wellness products. Aneesh commented before starting Q&A that companies should talk with FDA via a pre-submission (Q-sub) to discuss if a device is CDS software applicable to enforcement discretion. This is consistent with the General Wellness town hall, where he stated that companies that had questions regarding their wellness product should talk with FDA via a pre-submission (Q-sub) to discuss if enforcement discretion is applicable.
Some key questions that were raised and addressed by FDA included the following:
- Can an LLM be CDS software that meets Criterion 4? An LLM may meet Criterion 4 if it can provide sufficient support per Criterion 4 guidance.
- Why is the example on page 11 is the risk prediction of a cardiovascular event within 24 hrs a regulated device? The time critical nature for cardiovascular event is associated with the severity of a cardiovascular event, but not all CDS software that provide a warning of a potential event within 24 hours would necessarily be a regulated device.
- Is the inclusion of an alert or alarm in CDS software automatically a regulated device? Software functions with alert or alarm are not specifically regulated devices, but look to Criterion 4 to determine if there is sufficient time to consider a recommendation independently.
- Is CDS software used for acute care automatically a regulated device? Acute care may not be a regulated device, but look to Criterion 4 to determine if there is sufficient time to consider a recommendation independently.
- What usability evidence is needed for CDS Software? FDA has no recommendations on what usability needs are required for CDS software, but usability could cause a failure of Criterion 4.
- Is CDS software with a single risk score a regulated device? CDS software with a single risk score that meets all four criterion could be CDS software under enforcement discretion.
The clear statement by FDA that a LLM could be CDS software applicable to enforcement discretion in itself was a huge development. As with the prior general wellness town hall, it is clear from the CDS software town hall that companies need to consider the Q-sub process to discuss their products to stay consistent with the FDA’s expectations for CDS software under enforcement discretion. In fact, a number of the Q&A responses left enough ambiguity that a Q-sub seems highly necessary to solidify a safe harbor for enforcement discretion allowance. This is particularly the case for CDS software products that could be considered higher stakes, depending on the intended users, applicable condition or condition(s) and the usability of a product, which could impact the ability to meet Criterion 1-4 in the eyes of the FDA.
