FDA issues new guidance on AI-based medical devices

The FDA released a new guidance March 30 detailing how artificial intelligence and machine learning devices can be more effective for healthcare organizations and providers. 

The FDA said the guidance is applicable to machine learning-enabled device software functions that device manufacturers plan to modify over time.

Some of its recommendations include making sure AI and machine learning devices consider race, ethnicity, disease severity, gender, age and geography of data sets. 

The FDA seeks feedback on the draft guidance by July 3. Read the full guidance here.

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