The FDA’s fiscal 2027 guidance priorities elevate AI-enabled devices and robotically assisted surgical systems to the top of its regulatory agenda. The agency plans to finalize lifecycle and marketing guidance for AI devices and draft recommendations for generative AI conversational tools for mental disorders. It also aims to rapidly finalize draft premarket guidance for surgical robots, with public comment deadlines in late November. Additional priorities include respirators, menstrual product testing, quality systems and an accreditation scheme, while pulse oximeter guidance remains a second-tier item.
FDA Puts AI and Surgical Robots at Top of Fiscal 2027 Guidance Agenda
A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
The U.S. Food and Drug Administration this week published its fiscal 2027 guidance priorities, placing artificial intelligence and robotically assisted surgical devices at the top of its regulatory agenda for the coming 12 months.
AI Guidance: Lifecycle, Marketing and Generative Tools
Top priorities include finalizing guidance on marketing submissions and lifecycle management for AI-enabled medical devices and drafting recommendations specifically addressing generative AI. The agency is also prioritizing development of evidentiary recommendations for generative AI–enabled conversational tools aimed at treating or supporting people with mental disorders.
Surgical Robots: Swift Finalization Sought
The FDA recently published a draft guidance on premarket submissions for robotically assisted surgical devices that provides recommendations on nonclinical testing, clinical data and labeling for certain systems. The agency is accepting public comment on that draft through Nov. 24 and has said it intends to finalize the guidance within one year of draft publication.
Priority Lists and Deadlines
As in prior years, the FDA released categorized lists: priority final and draft guidances, additional documents to publish if resources permit, and texts currently under development. The prioritized set for fiscal 2027 contains seven final guidance documents (including one carryover from last year) and one draft text. The agency is accepting feedback on its overall priorities through Nov. 30.
Other Planned Finalizations
Newly prioritized final guidance documents include air-purifying respirators, menstrual product testing and labeling, quality management systems, and an accreditation scheme for conformity assessment. The agency also retained one carryover priority: finalizing guidance on predetermined change control plans for medical devices.
Second-Tier Priorities
Second-tier items for fiscal 2027 include finalizing guidance on pulse oximeters. The FDA issued a draft on those devices in January 2025 in response to concerns about accuracy across different skin pigmentations; the final guidance will address nonclinical and clinical performance testing, labeling and premarket submission recommendations for pulse oximeters used for medical purposes.
Public comment windows: Robotically assisted surgical devices draft — comments through Nov. 24; Overall priorities — comments through Nov. 30.
The FDA continues to signal increased regulatory focus on AI-enabled health products and faster completion of guidance for emerging medical technologies. Stakeholders should review the drafts, consider submitting feedback by the deadlines, and monitor the agency's published timelines for final guidance.
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