The US Food and Drug Administration (FDA) on Monday published a much-anticipated guidance on developing and managing medical devices with artificial intelligence (AI). The agency recommends taking a total product lifecycle (TPLC) approach to the products to ensure they meet their expectations for safety and efficacy.
The 67-page draft guidance details how to apply a TPLC approach to AI-enabled device development and management, how to consider issues such as user interface, address risks and data systems throughout the product lifecycle, and offers examples for submitting documentation to the agency…
