Artificial Intelligence in Breast Cancer Screening: Evaluation of FDA Device Regulation and Future Recommendations.

ABSTRACT:

Importance

Contemporary approaches to artificial intelligence (AI) based on deep learning have generated interest in the application of AI to breast cancer screening (BCS). The US Food and Drug Administration (FDA) has approved several next-generation AI products indicated for BCS in recent years; however, questions regarding their accuracy, appropriate use, and clinical utility remain.

Objectives

To describe the current FDA regulatory process for AI products, summarize the evidence used to support FDA clearance and approval of AI products indicated for BCS, consider the advantages and limitations of current regulatory approaches, and suggest ways to improve the current system.

Evidence review

Premarket notifications and other publicly available documents used for FDA

SUBMITTER: Potnis KC 

PROVIDER: S-EPMC10623674 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature