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