The evidence behind the guides

Sources

Find a study, check what it supports, and follow it back to a concern.

TopicCollection

Sources for Medical-device malfunctions

1 source

Guide citations are still under editorial review.

US Food and Drug Administration Draft guidance

AI-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (original source, new tab)

January 2025 draft recommendations on safety, performance and lifecycle management, not binding final requirements.

Sources retain their original publishers’ rights. Inclusion does not imply endorsement. Saved sources stay in this browser on this device. Dates and source descriptions come from the existing editorial records.