United States of America: Opened consultation on FDA draft Guidance on Artificial Intelligence-Enabled Device Software Functions including design requirements
Description
Opened consultation on FDA draft Guidance on Artificial Intelligence-Enabled Device Software Functions including design requirements
On 7 January 2025, the Food and Drug Administration (FDA) opened a public consultation on its draft Guidance for Industry and FDA Staff regarding the design requirements for Artificial Intelligence-Enabled Device Software Functions until 7 April 202…
Scope
Policy Area
Design and testing standards
Policy Instrument
Design requirement
Regulated Economic Activity
ML and AI development, other service provider
Implementation Level
national
Government Branch
executive
Government Body
other regulatory body