United States of America: Design requirements in FDA Guidance on Artificial Intelligence-Enabled Device Software Functions
Progress
Current status
processing consultation
07 Apr 2025 processing consultation
07 Jan 2025 in consultation
Scope
Implementers
United States of America
Policy Area
Design and testing standards
Policy Instrument
Design requirement
Regulated Economic Activity
ML and AI development
other service provider
Government Branch
executive
Government Body
other regulatory body
Implementation Level
national
Timeline of events
Closed consultation on FDA draft Guidance on Artificial Intelligence-Enabled Device Software Functions including design requirements
On 7 April 2025, the Food and Drug Administration (FDA) closes the public consultation on its draft Guidance for Industry and FDA Staff regarding the design requirements for Artificial Intelligence-Enabled Device Software Functions.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…
SourceEvent type
outline
Action type
consultation closed
Government branch
executive
Government body
other regulatory body
Opened consultation on FDA draft Guidance on Artificial Intelligence-Enabled Device Software Functions including design requirements
On 7 January 2025, the Food and Drug Administration (FDA) opened a public consultation on its draft Guidance for Industry and FDA Staff regarding the design requirements for Artificial Intelligence-Enabled Device Software Functions until 7 April 202…
SourceEvent type
outline
Action type
consultation opened
Government branch
executive
Government body
other regulatory body