United States of America: Closed consultation on FDA draft Guidance on Artificial Intelligence-Enabled Device Software Functions including design requirements
Description
Closed consultation on FDA draft Guidance on Artificial Intelligence-Enabled Device Software Functions including design requirements
On 7 April 2025, the Food and Drug Administration (FDA) closes the public consultation on its draft Guidance for Industry and FDA Staff regarding the design requirements for Artificial Intelligence-Enabled Device Software Functions. The draft guidan…
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