Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Feb 1;179(2):212-214.
doi: 10.1001/jamapediatrics.2024.5437.

US FDA Approval of Pediatric Artificial Intelligence and Machine Learning-Enabled Medical Devices

Ryan C L Brewster  1 , Matthew Nagy  1 , Susmitha Wunnava  2 , Florence T Bourgeois  1   2   3
Affiliations

US FDA Approval of Pediatric Artificial Intelligence and Machine Learning-Enabled Medical Devices

Ryan C L Brewster et al. JAMA Pediatr. .
No abstract available

Plain language summary

This cross-sectional study analyzes the availability of artificial intelligence and machine learning–enabled devices authorized for children by the US Food and Drug Administration (FDA) and assesses reporting of algorithm validation in the pediatric population.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure.
Figure.. Trends in Annual US Food and Drug Administration (FDA) Authorization of Artificial Intelligence/Machine Learning (AI/ML)-Enabled Medical Devices
See this image and copyright information in PMC

References

    1. Bourgeois FT, Espinoza JC. Advancing equity in medical device development for children. JAMA Pediatr. 2023;177(6):561-562. doi:10.1001/jamapediatrics.2023.0790 - DOI - PubMed
    1. Sammer MBK, Akbari YS, Barth RA, et al. . Use of artificial intelligence in radiology: impact on pediatric patients, a white paper from the ACR Pediatric AI Workgroup. J Am Coll Radiol. 2023;20(8):730-737. doi:10.1016/j.jacr.2023.06.003 - DOI - PubMed
    1. Espinoza J, Shah P, Nagendra G, Bar-Cohen Y, Richmond F. Pediatric medical device development and regulation: current state, barriers, and opportunities. Pediatrics. 2022;149(5):e2021053390. doi:10.1542/peds.2021-053390 - DOI - PubMed
    1. US Food and Drug Administration . Marketing submission recommendations for a predetermined change control plan for artificial intelligence/machine learning (AI/ML)-enabled device software functions: draft guidance for industry and Food and Drug Administration staff. Accessed June 1, 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents...
    1. US Food and Drug Administration . Artificial intelligence and machine learning (AI/ML)-enabled medical devices. Accessed March 31, 2024. https://www.fda.gov/medical-devices/software-medical-device-samd/artific...