A scoping review of reporting gaps in FDA-approved AI medical devices

Abstract

Machine learning and artificial intelligence (AI/ML) models in healthcare may exacerbate health biases. Regulatory oversight is critical in evaluating the safety and effectiveness of AI/ML devices in clinical settings. We conducted a scoping review on the 692 FDA-approved AI/ML-enabled medical devices approved from 1995-2023 to examine transparency, safety reporting, and sociodemographic representation. Only 3.6% of approvals reported race/ethnicity, 99.1% provided no socioeconomic data. 81.6% did not report the age of study subjects. Only 46.1% provided comprehensive detailed results of performance studies; only 1.9% included a link to a scientific publication with safety and efficacy data. Only 9.0% contained a prospective study for post-market surveillance. Despite the growing number of market-approved medical devices, our data shows that FDA reporting data remains inconsistent. Demographic and socioeconomic characteristics are underreported, exacerbating the risk of algorithmic bias and health disparity.

Fig. 1. Trends in FDA licensing of AI/ML-enabled medical devices.

The blue bars show the number of Food and Drug Administration (FDA) approvals for medical devices from 1995 to 2023. The red line plot shows the number of FDA approvals for AI/ML-enabled medical devices that are licensed for children. Total number of FDA approvals for AI/ML-enabled medical devices have increased steeply since 2016. FDA approvals for children-licensed devices have increased steadily since 2018.

Fig. 2. FDA-assigned medical specialty.

Distribution of medical specialties represented in 692 FDA approvals between 1995 and 2023.

Fig. 3. Reported information on intended subjects.

Number of FDA summary documents providing relevant sociodemographic information about intended subjects of medical device. a Only 14 (2.0%) summary documents lacked clearly stated indications for the use of the medical device. b The majority (667; 96.4%) of the documents did not provide any information about race/ethnicity of intended subjects and how this may impact the application of the device. c The majority (686; 99.1%) of the documents did not provide any information about socioeconomic context of intended subjects.

Fig. 4. Accessibility to publications supporting safety, efficacy, and transparency.

Only few summary documents provide a means of accessing published scientific publication that validates the use of the medical device.

Fig. 5. FDA approvals for pediatrics-licensed medical devices.

The proportion of total FDA approvals a licensed for children is 10.0% b tested and validated in both children and adults is 19.4%. c Radiology has the highest representation among FDA-approved devices for children.