Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting.

ABSTRACT: Background: The US Food and Drug Administration (FDA) authorized over 690 machine learning (ML)-enabled medical devices between 1995 and 2023. In 2024, new guidance enabled the inclusion of Predetermined Change Control Plans (PCCPs), raising expectations for transparency, equity, and safety under the Good Machine Learning Practice (GMLP) framework. Objective: The objective was to assess regulatory pathways, predicate lineage, demographic transparency, performance reporting, and PCCP uptake among ML-enabled devices approved by the FDA in 2024. Methods: We conducted a cross-sectional analysis of all FDA-authorized ML-enabled devices in 2024. Data extracted from FDA summaries included regulatory pathway, predicate genealogy, performance metrics, demographic disclosures, P

SUBMITTER: Almarie B 

PROVIDER: S-EPMC12730494 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature