FDA Releases Draft Guidance On Submission Recommendations For AI-Enabled Device Software Functions

On January 7, 2025, FDA published a draft guidance titled "Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations." The draft guidance was long-anticipated; it was on FDA's "A list" for FDA to publish in fiscal year 2024 (i.e., prior to September 30, 2024) and then transferred to the fiscal year 2025 "A list" when that deadline was missed.

The draft guidance provides recommendations on the content of marketing submissions (e.g., 510(k) premarket notifications, premarket approval applications) for devices that include artificial intelligence (AI)-enabled device software functions. The draft guidance also provides recommendations on the design and development of AI-enabled devices throughout the total product life cycle (TPLC).