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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Topics: AI (Artificial Intelligence), FDA, Govt Agencies, Medical Devices, Technology
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