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

How comprehensively are efficacy, safety, and risk assessments reported for artificial intelligence (AI)/machine learning (ML)−enabled devices cleared by the US Food and Drug Administration (FDA)?This cross-sectional study of 691 FDA-cleared AI/ML devices found that key elements were frequently unreported, including study design (323 devices [46.7%]), training sample size (385 [53.3%]), and demographic representation (660 [95.5%]), with only 6 devices (1.6%) reporting data from randomized clinical trials, and 3 (<1%) reporting patient outcomes. Premarket safety assessments were documented for 195 devices (28.2%) and postmarket adverse events, including 1 death, were reported for 36 devices (5.2%).These findings indicate that standardized efficacy, safety, and risk assessment reporting remains inadequate for FDA-cleared AI/ML devices, underscoring the need for dedicated regulatory pathways and robust postmarket surveillance to ensure patient safety.

Corresponding Author: Ravi B. Parikh, MD, MPP, Department of Hematology and Medical Oncology, Winship Cancer Institute, 1750 Haygood Dr NE, Atlanta, GA 30307 (ravi.bharat.parikh@emory.edu).

Link to the article in your story

We encourage you to link out to this article in your story using the link below. It includes an access token that will give free access to the article for your readers up to one year after publication. (The link will be live after the article publishes and embargo is lifted.)

Please see the article for additional information, including full author list, author contributions and affiliations, conflict of interest and financial disclosures, and funding and support.

Need more information? Contact us.