The FDA has outlined its guidance priorities for the 2027 fiscal year, with a focus on artificial intelligence and surgical robots. The agency plans to finalize and draft documents related to AI-enabled devices, including guidance on marketing submissions and lifecycle management.
The FDA’s top priorities include finalizing guidance on premarket submissions of robotically assisted surgical devices, which was published in draft form last week. They are also prioritizing the drafting of evidentiary recommendations on generative AI-enabled conversational devices for mental disorders.
In addition to AI and surgical robots, the FDA is prioritizing guidance on other medical devices, including air-purifying respirators, menstrual product testing and labeling, and quality management systems.
The FDA is accepting feedback on its priorities until November 30. The agency’s guidance priorities are divided into two tiers, with the first tier including seven final guidance documents and one draft text. Second-tier priorities include finalizing guidance on pulse oximeters, which will cover nonclinical and clinical performance testing, labeling, and premarket submission recommendations.
The FDA’s focus on AI and surgical robots reflects the agency’s recent activities, including an August call for feedback on regulating generative AI. Other guidelines prioritized for finalization in the coming year include texts on accreditation schemes for conformity assessment.
The FDA is accepting feedback on its priorities until Nov. 30. In January 2025, the FDA published the draft version of the guidance on lifecycle management for AI-enabled devices now prioritized for finalization. The recently published draft guidance provided recommendations on nonclinical testing, clinical data and labeling for certain surgical robots.
The FDA has yet to finalize guidance on predetermined change control plans for medical devices, but plans to do so in the coming 12 months. The FDA has proposed lists of priority final and draft guidances, lists of documents it will publish if resources permit and a list of texts that are under construction. The FDA released draft guidance on pulse oximeters in January 2025, responding to concerns about the effect of skin pigmentation on accuracy.
