At a glance
What this entry covers
Evaluate FDA AI/ML-based Software as Medical Device compliance per 2021 guidance, covering predetermined/adaptive algorithms, algorithm change protocols, and real-world performance monitoring
MyRHC indexes this framework so practitioners, auditors, and automated agents can find the authoritative primary sources in one place. This page is a navigation aid — it is not legal advice and is not a substitute for the official text.
Official documentation
- Primary official source: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device
How to use this index entry
- Open the official link above (or the agency home if the deep link drifts).
- Confirm edition / revision date against your program scope.
- Map applicability by sector and jurisdiction listed in the metadata.
- Follow related frameworks only after checking their own official sources.
Disclaimers
- MyRHC does not host proprietary standards text (ISO, some industry bodies).
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- Always verify current requirements with counsel and the issuing authority.
Index only — not legal advice.
MyRHC does not certify compliance. Confirm current requirements with the issuing authority and qualified counsel. Proprietary standards text remains with its publisher.