Dive Brief:
- The Food and Drug Administration published its fiscal 2027 guidance priorities Thursday, setting itself the goal of finalizing and drafting artificial intelligence documents.
- Over the coming 12 months, the FDA’s top priorities include finalizing guidance on marketing submissions and lifecycle management for AI-enabled devices and drafting generative AI advice.
- The agency is also prioritizing the swift finalization of its guidance on premarket submissions of robotically assisted surgical devices, which it published in draft form last week.
Dive Insight:
As in previous years, 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 priority lists feature seven final guidance documents, including one holdover from last year, and one draft text. 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 agency made finalizing the draft a second-tier objective in last year’s list.
This year, the FDA is prioritizing drafting evidentiary recommendations on generative AI-enabled conversational devices for mental disorders. The topic was absent from last year’s list but is aligned with the FDA’s recent activities, including an August call for feedback on regulating generative AI.
The FDA also aims to finalize guidance on premarket submissions of robotically assisted surgical devices in the coming year. The recently published draft guidance provided recommendations on nonclinical testing, clinical data and labeling for certain surgical robots. The FDA, which is accepting feedback until Nov. 24, aims to finalize the document within one year of publishing the draft.
Other guidelines prioritized for finalization in the coming year include texts on air-purifying respirators, menstrual product testing and labeling, quality management systems and the accreditation scheme for conformity assessment.
Those documents are all new priorities. There is also one holdover from last year. 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. Another priority from last year, which covered the validation of certain in vitro diagnostics, has yet to be finalized and is not on the list for the coming year.
Second-tier priorities for the 2027 fiscal year include finalizing guidance on pulse oximeters. The FDA guidance will cover nonclinical and clinical performance testing, labeling and premarket submission recommendations for pulse oximeters for medical purposes. Responding to concerns about the effect of skin pigmentation on accuracy, the FDA released draft guidance on pulse oximeters in January 2025.
