src_6f376f8e8faa8c850c
- Source-provided label
- Not reported
- Evidence class
- mentioned in report
- Confidence
- Not reported
- Observed
- Not reported
- Retrieved
- Oct 08, 2026 03:44 UTC
How FDA's Draft Guidance Shapes AI Medical Device Safety
FDA's draft guidance for AI-enabled medical devices reflects a major change in how regulators address software that changes over time, recognizing AI's ability to evolve while emphasizing patient safety, transparency and accountability, said Phil Englert of the Health-ISAC.
Reference details
- Source category
- Research & news
- Report title
How FDA's Draft Guidance Shapes AI Medical Device Safety- First reported
- Not reported
- Last reported
- Not reported
- Catalog updated
- Oct 08, 2026 03:44 UTC
- Record ID
02bac8c09b4e73950bf61bc49c361549452902a502df60ac00284159ccc6517e
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