FDA Clearance

Intermediate

US approval process for medical AI devices.

Full Definition

US approval process for medical AI devices.

Keywords

regulatory approval

Domains

AI in Healthcare

Related Terms

SaMD related to

Software regulated as a medical device.

 Dataset Shift related to

Differences between training and deployed patient populations.

 Algorithmic Bias related to

Unequal performance across demographic groups.

 Informed Consent related to

Patient agreement to AI-assisted care.

 Triage System related to

AI that ranks patients by urgency.

 Risk Stratification related to

Grouping patients by predicted outcomes.

 Prognostic Model related to

Predicting disease progression or survival.

 Clinical Validation related to

Testing AI under actual clinical conditions.

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