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- FDA Publishes Guidance for AI Premarket Submissions
The FDA published guidance for premarket submission of artificial intelligence/machine learning (AI/ML) medical software on December 3. The guidance details information manufacturers should include in an FDA premarket submission so that they can alter their AI/ML software over time without needing to complete another FDA marketing submission.
In a June 2023 letter, the CAP supported concepts proposed within the initial draft guidance. The letter requested transparency in labeling so pathologists and other physicians have useful information from manufacturers to oversee the implementation and monitor performance of that AI/ML software. Read the CAP’s June 2023 comments to the FDA.
The FDA stated that it revised definitions of the terms “artificial intelligence” and “machine learning” to align with an executive order from October 2023.