HHS / FDA AI and health guidance
Assessment outcome
total 5/6 (actionability 1 + authority 2 + currency 2)
Eligibility gates
HTTP 200, 1412 words of full text extracted
The page focuses primarily on artificial intelligence and machine learning technologies in medical devices.
The source addresses regulatory frameworks, guidance documents, and oversight for AI medical devices.
Issued by the United States government Food and Drug Administration (FDA).
No evidence on the page indicates this guidance has been superseded, repealed, or withdrawn.
Scored criteria
Actionability
1/2Level 1: Provides general direction and principles regarding medical product life cycle management without detailing specific binding implementation steps.
The complex and dynamic processes involved in the development, deployment, use, and maintenance of AI technologies benefit from careful management throughout the medical product life cycle.
Authority
2/2Level 2: Official government document issued by the United States government (FDA).
An official website of the United States government Here’s how you know The.gov means it’s official.
Currency
2/2computed: newest date 2025-03-25 (via time-tag), ~1.4y old; within the 36-month standards_frameworks window for perspective 'Regulatory/legal' → 2