FDA creates transparency principles for AI in medical devices

MedTech Dive June 17, 2024
Nick Paul Taylor

The agency worked with regulators in the U.K. and Canada to determine how key information about machine learning-enabled devices should be communicated.

Dive Brief:

• The Food and Drug Administration and its international partners have created guiding principles for transparency for machine learning-enabled medical devices, the agency said Thursday.
• Working with its counterparts in Canada and the U.K., the FDA has developed the principles to ensure information that could affect risks and patient outcomes is communicated.
• The agencies explained what information device developers should communicate and how they should get it to users to provide the industry with best transparency practices.

Dive Insight:

The FDA, Health Canada and the U.K.’s Medicines and Healthcare products Regulatory Agency jointly identified...

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