Benefit-Risk Reporting for FDA-Cleared Artificial Intelligence-Enabled Medical Devices.

ABSTRACT:

Importance

Devices enabled by artificial intelligence (AI) and machine learning (ML) are increasingly used in clinical settings, but there are concerns regarding benefit-risk assessment and surveillance by the US Food and Drug Administration (FDA).

Objective

To characterize pre- and postmarket efficacy, safety, and risk assessment reporting for FDA-cleared AI/ML devices.

Design and setting

This was a cross-sectional study using linked data from FDA decision summaries and approvals databases, the FDA Manufacturer and User Facility Device Experience Database, and the FDA Medical Device Recalls Database for all AI/ML devices cleared by the FDA from September 1995 to July 2023. Data were analyzed from October to November 2024.

Main outcomes and measures

AI/ML repor

SUBMITTER: Lin JC 

PROVIDER: S-EPMC12475944 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature