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# Strengthen AI Product Approval: Researchers
- URL: https://www.fdaweb.com/strengthen-ai-product-approval-researchers/
- Published: 2022-11-10T12:00:00.000Z
- Updated: 2026-09-14T18:05:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153171

Yale University researchers say that with the role of artificial intelligence (AI) in breast cancer screening likely to grow in the next decade, it is important that FDA increase evidentiary regulatory standards, develop improved postmarketing surveillance and trials, and engage key stakeholders to help ensure that new AI products meet the goal of improving the outcome of breast cancer screening. Writing in a *JAMA Internal Medicine* special communication, the researchers [say](https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2797770?ref=fdaweb.com) AI applications have been proposed to improve accuracy and for reducing radiologist mammography reading time and cognitive load.

The report describes the current FDA regulatory process for AI products and looks at the application of the process to nine AI products indicated for breast cancer screening.

“The findings of this review suggest important gaps in reporting of data sources, data set type, validation approach, and clinical utility assessment,” the researchers conclude.